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

Radioimmunoassay, Glucagon

21 CFR 862.1335 / Clinical Chemistry
FDA source (opens on fda.gov)

JME is the FDA product code for Radioimmunoassay, Glucagon, a class I device type, regulated under 21 CFR 862.1335. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JME
Device name
Radioimmunoassay, Glucagon
Regulation
21 CFR 862.1335
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
3
Ingested recalls
0

Clearances, product code JME

By decision year
3 clearances under product code JME with a decision year between 1978 and 1989, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JME by decision year
YearClearances
19781
19791
19891

Applicants with the most clearances

Product code JME
Applicants holding the most 510(k) clearances under product code JME
ApplicantClearances
Siemens Healthcare Diagnostics Inc.1
Inter Science Institute1
Serono Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code