510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970189Substantially Equivalent

Fif Tm

Panbio Limited, South Bend IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970189 is the FDA 510(k) clearance record for FIF TM, a class II device, cleared for Panbio, Inc. on under FDA product code KQJ (System, Fibrinogen Determination). FDA records list 8 510(k) clearances for Panbio, Inc., from to . As of , FDA records show no recalls naming K970189.

Clearance record

Decision date
Received
(120 days to decision)
Product code
KQJ System, Fibrinogen Determination
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
Panbio, Inc. 1539 N. Ironwood Dr., South Bend IN
510(k) summary
Summary
Third party review
No

Clearances, product code KQJ

Trailing 12 months

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

FDA records show no clearances under product code KQJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQJ, 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