FDA 510(k) Applications for Medical Device Product Code "CIO"
(Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes)

FDA 510(k) Number Applicant Device Name Decision Date
K781324 ANALYTICAL & RESEARCH CHEMICALS, INC. ALP TEST 08/31/1978
K823578 HOFFMANN-LA ROCHE, INC. COBAS STANDARDS FOR CALCIUM-IN-ORGANIC 01/07/1983
K770453 ICN PHARMACEUTICALS, INC. PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE 05/03/1977
K844237 LIVONIA DIAGNOSTICS, INC. ALKALINE PHOSPHATASE REAGENT SET 11/20/1984
K841064 MEDICAL SPECIALTIES, INC. ALKALINE PHOSPHOTASE REAGENT SET 05/01/1984
K821200 OMEGA MEDICAL ELECTRONICS ALKALINE PHOSPHOTASE REAGENT SET 07/13/1982
K844498 SANDARE CHEMICAL CO., INC. SANDARE ALKALINE PHOSPHATASE PROCEDURE 12/10/1984
K772257 STANBIO LABORATORY ALKALINE PHOSPHATASE TEST SET 12/22/1977
K860351 STERLING DIAGNOSTICS, INC. ALKALINE PHOSPHATASE REAGENT SET 02/11/1986
K880177 TECH-CO, INC. ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT 04/05/1988
K855192 TECHNOSTICS INTL. ALKALINE PHOSPHATASE REAGENT SET 01/14/1986


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