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

Starch-Dye Bound Polymer, Amylase

21 CFR 862.1070 / Clinical Chemistry
FDA source (opens on fda.gov)

CIW is the FDA product code for Starch-Dye Bound Polymer, Amylase, a class II device type, regulated under 21 CFR 862.1070. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
CIW
Device name
Starch-Dye Bound Polymer, Amylase
Regulation
21 CFR 862.1070
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
8
Ingested recalls
5

Clearances, product code CIW

By decision year
8 clearances under product code CIW with a decision year between 1979 and 1993, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CIW by decision year
YearClearances
19791
19813
19851
19891
19921
19931

Applicants with the most clearances

Product code CIW
Applicants holding the most 510(k) clearances under product code CIW
ApplicantClearances
Bio-Analytics Laboratories, Inc.1
Boehringer Mannheim Corp.1
Calbiochem-Behring Corp.1
Data Medical Associates, Inc.1
Eastman Kodak Company1
Em Diagnostic Systems, Inc.1
Olympus Corp.1
Pharmacia, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code