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

Hydrazone Colorimetry, Alt/Sgpt

21 CFR 862.1030 / Clinical Chemistry
FDA source (opens on fda.gov)

CKD is the FDA product code for Hydrazone Colorimetry, Alt/Sgpt, a class I device type, regulated under 21 CFR 862.1030. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
CKD
Device name
Hydrazone Colorimetry, Alt/Sgpt
Regulation
21 CFR 862.1030
Device class
Class I
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
11
Ingested recalls
2

Clearances, product code CKD

By decision year
11 clearances under product code CKD with a decision year between 1982 and 1999, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code CKD by decision year
YearClearances
19822
19842
19862
19882
19901
19951
19991

Applicants with the most clearances

Product code CKD
Applicants holding the most 510(k) clearances under product code CKD
ApplicantClearances
Anco Medical Reagents & Assoc.1
Boehringer Mannheim Corp.1
Cholestech Corp.1
Electro-Nucleonics, Inc.1
Livonia Diagnostics, Inc.1
Medical Specialties Inc.1
Omega Medical Electronics1
Ortho Diagnostic Systems, Inc.1
Roche Diagnostic Systems, Inc.1
Sterling Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code