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

Ph Buffer

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

JCC is the FDA product code for Ph Buffer, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JCC
Device name
Ph Buffer
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
7
Ingested recalls
2

Clearances, product code JCC

By decision year
7 clearances under product code JCC with a decision year between 1977 and 1984, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JCC by decision year
YearClearances
19771
19801
19812
19843

Applicants with the most clearances

Product code JCC
Applicants holding the most 510(k) clearances under product code JCC
ApplicantClearances
E K Ind., Inc.2
Bioscientific1
Dutchland Laboratories, Inc.1
Electrophoresis Corp. of America1
Mid Tech, Inc.1
Reagent Laboratory, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order