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

Cuvette, Thermostated

21 CFR 862.2050 / Clinical Chemistry
FDA source (opens on fda.gov)

JRI is the FDA product code for Cuvette, Thermostated, a class I device type, regulated under 21 CFR 862.2050. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JRI
Device name
Cuvette, Thermostated
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code JRI

By decision year
4 clearances under product code JRI with a decision year between 1976 and 1987, 1976 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JRI by decision year
YearClearances
19762
19781
19871

Applicants with the most clearances

Product code JRI
Applicants holding the most 510(k) clearances under product code JRI
ApplicantClearances
Coulter Electronics, Inc.1
Gilford Instrument Laboratories, Inc.1
Medatron, Inc.1
Revvity Health Sciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order