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

Hydrazone Colorimetry, Ast/Sgot

21 CFR 862.1100 / Clinical Chemistry
FDA source (opens on fda.gov)

CIS is the FDA product code for Hydrazone Colorimetry, Ast/Sgot, a class II device type, regulated under 21 CFR 862.1100. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CIS
Device name
Hydrazone Colorimetry, Ast/Sgot
Regulation
21 CFR 862.1100
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code CIS

By decision year
5 clearances under product code CIS with a decision year between 1979 and 2003, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CIS by decision year
YearClearances
19791
19811
19851
19901
20031

Applicants with the most clearances

Product code CIS
Applicants holding the most 510(k) clearances under product code CIS
ApplicantClearances
Cholestech Corp.1
Clinical Data, Inc.1
Instrumentation Laboratory Co.1
Roche Diagnostic Systems, Inc.1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code