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

Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

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

CIN is the FDA product code for Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a class II device type, regulated under 21 CFR 862.1050. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
CIN
Device name
Electrophoretic Separation, Alkaline Phosphatase 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
26
Ingested recalls
7

Clearances, product code CIN

By decision year
26 clearances under product code CIN with a decision year between 1976 and 2024, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CIN by decision year
YearClearances
19761
19772
19801
19811
19821
19831
19871
19893
19911
19921
19942
19951
19961
19972
19981
20001
20011
20021
20051
20201
20241

Applicants with the most clearances

Product code CIN
Applicants holding the most 510(k) clearances under product code CIN
ApplicantClearances
Helena Laboratories, Corp.5
Hybritech, Inc.3
Siemens Healthcare Diagnostics Inc.2
Metra Biosystems, Inc.2
Sigma Chemical Co.2
Beckman Instruments, Inc.1
Behring Diagnostics, Inc.1
Bioware Products1
California Immuno Diagnostic, Inc.1
Ciba Corning Diagnostics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code