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

Column Chromatography & Color Development, Hydroxyproline

21 CFR 862.1400 / Clinical Chemistry
FDA source (opens on fda.gov)

JMM is the FDA product code for Column Chromatography & Color Development, Hydroxyproline, a class I device type, regulated under 21 CFR 862.1400. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JMM
Device name
Column Chromatography & Color Development, Hydroxyproline
Regulation
21 CFR 862.1400
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
21
Ingested recalls
2

Clearances, product code JMM

By decision year
21 clearances under product code JMM with a decision year between 1977 and 2001, 1998 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JMM by decision year
YearClearances
19771
19954
19963
19972
19985
19994
20001
20011

Applicants with the most clearances

Product code JMM
Applicants holding the most 510(k) clearances under product code JMM
ApplicantClearances
Metra Biosystems, Inc.5
Ostex Intl., Inc.5
Siemens Healthcare Diagnostics Inc.2
Bayer Corp.1
Ciba Corning Diagnostics Corp.1
Devices and Diagnostics Consulting Group1
Diagnostic Systems Laboratories, Inc.1
Metrika, Inc.1
Organon LLC1
Ortho-Clinical Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code