510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PPMClass I

General Purpose Reagent

21 CFR 864.4010 / Pathology
FDA source (opens on fda.gov)

PPM is the FDA product code for General Purpose Reagent, a class I device type, regulated under 21 CFR 864.4010. FDA's definition for this code reads: "A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or...". As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 30 recalls.

Classification record

Product code
PPM
Device name
General Purpose Reagent
FDA definition
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
16
Ingested recalls
30

Clearances, product code PPM

By decision year
16 clearances under product code PPM with a decision year between 1981 and 1987, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code PPM by decision year
YearClearances
19812
19822
19832
19844
19853
19862
19871

Applicants with the most clearances

Product code PPM
Applicants holding the most 510(k) clearances under product code PPM
ApplicantClearances
Richard-Allan Medical Ind., Inc.3
E K Ind., Inc.2
Omega Medical Diagnostics2
Anatech, Ltd.1
Interscience Diagnostics, Inc.1
Interscience, Inc.1
Micro Media Laboratories1
Reagent Laboratory, Inc.1
Remel Inc1
Roseville Medical Laboratoriesu1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 231 companies shown, in name order