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

Lipase-Esterase, Enzymatic, Photometric, Lipase

21 CFR 862.1465 / Clinical Chemistry
FDA source (opens on fda.gov)

CHI is the FDA product code for Lipase-Esterase, Enzymatic, Photometric, Lipase, a class I device type, regulated under 21 CFR 862.1465. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 22 recalls.

Classification record

Product code
CHI
Device name
Lipase-Esterase, Enzymatic, Photometric, Lipase
Regulation
21 CFR 862.1465
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
20
Ingested recalls
22

Clearances, product code CHI

By decision year
20 clearances under product code CHI with a decision year between 1977 and 1997, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CHI by decision year
YearClearances
19771
19801
19811
19851
19861
19871
19883
19902
19922
19942
19953
19961
19971

Applicants with the most clearances

Product code CHI
Applicants holding the most 510(k) clearances under product code CHI
ApplicantClearances
Beckman Instruments, Inc.2
Eastman Kodak Company2
Nuclear Diagnostics, Inc.2
FUJIFILM Healthcare Americas Corporation2
Abbott Medical1
Advocacy International, Ltd.1
American Research Products Co.1
Biodynamics Corp.1
Boehringer Mannheim Corp.1
Calbiochem1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order