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

Colorimetric Method, Triglycerides

21 CFR 862.1705 / Clinical Chemistry
FDA source (opens on fda.gov)

JGY is the FDA product code for Colorimetric Method, Triglycerides, a class I device type, regulated under 21 CFR 862.1705. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JGY
Device name
Colorimetric Method, Triglycerides
Regulation
21 CFR 862.1705
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
22
Ingested recalls
2

Clearances, product code JGY

By decision year
22 clearances under product code JGY with a decision year between 1977 and 2012, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JGY by decision year
YearClearances
19771
19781
19792
19802
19821
19831
19861
19892
19902
19911
19942
19951
19971
20002
20031
20121

Applicants with the most clearances

Product code JGY
Applicants holding the most 510(k) clearances under product code JGY
ApplicantClearances
Abaxis Inc2
Data Medical Associates, Inc.2
Polymer Technology Systems2
Cholestech Corp.1
Dade, Baxter Travenol Diagnostics, Inc.1
Derma Media Lab., Inc.1
Enzyme Technology, Inc.1
Gilford Diagnostics1
Kulzer GmbH1
Instrumentation Laboratory Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order