CIO · Class II · 21 CFR 862.1050

FDA Product Code CIO: Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

Leading manufacturers include Icn Pharmaceuticals, Inc., Stanbio Laboratory and Omega Medical Electronics.

11
Total
11
Cleared
38d
Avg days
1977
Since

FDA 510(k) Cleared Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes Devices (Product Code CIO)

11 devices
1–11 of 11
Cleared Apr 05, 1988
ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
K880177
Tech-Co, Inc.
Chemistry · 81d
Cleared Feb 11, 1986
ALKALINE PHOSPHATASE REAGENT SET
K860351
Sterling Diagnostics, Inc.
Chemistry · 12d
Cleared Jan 14, 1986
ALKALINE PHOSPHATASE REAGENT SET
K855192
Technostics Intl.
Chemistry · 19d
Cleared Dec 10, 1984
SANDARE ALKALINE PHOSPHATASE PROCEDURE
K844498
Sandare Chemical Co., Inc.
Chemistry · 20d
Cleared May 01, 1984
ALKALINE PHOSPHOTASE REAGENT SET
K841064
Medical Specialties, Inc.
Chemistry · 50d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
K823578
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jul 13, 1982
ALKALINE PHOSPHOTASE REAGENT SET
K821200
Omega Medical Electronics
Chemistry · 77d
Cleared Dec 22, 1977
ALKALINE PHOSPHATASE TEST SET
K772257
Stanbio Laboratory
Chemistry · 17d
Cleared May 03, 1977
PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE
K770453
Icn Pharmaceuticals, Inc.
Chemistry · 56d

About Product Code CIO - Regulatory Context