510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CIOClass II

Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

21 CFR 862.1050 / Clinical Chemistry
FDA source (opens on fda.gov)

CIO is the FDA product code for Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1050. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CIO
Device name
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
11
Ingested recalls
0

Clearances, product code CIO

By decision year
11 clearances under product code CIO with a decision year between 1977 and 1988, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CIO by decision year
YearClearances
19772
19781
19821
19831
19843
19862
19881

Applicants with the most clearances

Product code CIO
Applicants holding the most 510(k) clearances under product code CIO
ApplicantClearances
Analytical & Research Chemicals, Inc.1
Hoffmann-La Roche, Inc.1
Icn Pharmaceuticals, Inc.1
Livonia Diagnostics, Inc.1
Medical Specialties Inc.1
Omega Medical Electronics1
Sandare Chemical Co., Inc.1
Stanbio Laboratory1
Sterling Diagnostics, Inc.1
Tech-Co, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code