FDA 510(k) Applications for Medical Device Product Code "LHT"
(Staphylococcus Aureus Somatic Antigens)

FDA 510(k) Number Applicant Device Name Decision Date
K820683 AMERICAN SCIENTIFIC PRODUCTS STAPHYLOCOCCUS LATEX AGGLUTINATION KIT 04/14/1982
K820347 CARR-SCARBOROUGH MICROBIOLOGICALS, INC. ACCU-STAPH 03/04/1982
K812434 DIAGNOSTICA, INC. DIAGNOSTIC KITS & KIT COMPONENTS 09/23/1981
K812374 DUTCHLAND LABORATORIES, INC. ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. 09/09/1981
K812375 DUTCHLAND LABORATORIES, INC. BABY CHICK BLOOD IN ALSEVER'S 09/09/1981
K812367 DUTCHLAND LABORATORIES, INC. GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) 09/09/1981
K812372 DUTCHLAND LABORATORIES, INC. GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF 09/09/1981
K812373 DUTCHLAND LABORATORIES, INC. RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR 09/09/1981
K812368 DUTCHLAND LABORATORIES, INC. RAT BLOOD IN ALSEVER'S, CITRATED 09/09/1981
K812376 DUTCHLAND LABORATORIES, INC. SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR 09/09/1981
K820531 MERIDIAN DIAGNOSTICS, INC. ENDO-STAPH TEICHOIC ACID ANTIBODY KIT 04/14/1982
K874303 OXOID U.S.A., INC. STAPHYLASE TEST 11/06/1987
K863025 SCOTT LABORATORIES, INC. SERO-STAT R II STAPHYLOCOCCUS TEST 09/15/1986


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