510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881380Substantially Equivalent

B. Fragtex

American Biomedical Products, Inc., Tulsa OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881380 is the FDA 510(k) clearance record for B. FRAGTEX, a class I device, cleared for American Biomedical Products, Inc. on under FDA product code JSP (Kit, Anaerobic Identification). FDA records list one 510(k) clearance for American Biomedical Products, Inc. As of , FDA records show no recalls naming K881380.

Clearance record

Decision date
Received
(188 days to decision)
Product code
JSP Kit, Anaerobic Identification
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
American Biomedical Products, Inc. P.O. Box 690355, Tulsa OK
Third party review
No

Clearances, product code JSP

Trailing 12 months

FDA records hold no clearances under product code JSP in the trailing twelve months.

FDA records show no clearances under product code JSP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JSP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260