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
JPHClass I

Test, Erythrocyte Sedimentation Rate

21 CFR 864.6700 / Hematology
FDA source (opens on fda.gov)

JPH is the FDA product code for Test, Erythrocyte Sedimentation Rate, a class I device type, regulated under 21 CFR 864.6700. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JPH
Device name
Test, Erythrocyte Sedimentation Rate
Regulation
21 CFR 864.6700
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code JPH

By decision year
7 clearances under product code JPH with a decision year between 1982 and 1987, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JPH by decision year
YearClearances
19821
19832
19841
19851
19861
19871

Applicants with the most clearances

Product code JPH
Applicants holding the most 510(k) clearances under product code JPH
ApplicantClearances
Ulster Scientific, Inc.3
American Dade1
Cordis US Corp.1
Microwave Development, Inc.1
Precision Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order