510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083729Substantially Equivalent

Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act. Pc-R Control Plasma and Biophen

Aniara Diagnostica LLC, Mason OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083729 is the FDA 510(k) clearance record for HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN, a class II device, cleared for Aniara Diagnostica, LLC on under FDA product code GGW (Test, Time, Partial Thromboplastin). FDA records list one 510(k) clearance for Aniara Diagnostica, LLC. As of , FDA records show no recalls naming K083729.

Clearance record

Decision date
Received
(143 days to decision)
Product code
GGW Test, Time, Partial Thromboplastin
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
Aniara Diagnostica, LLC 6560 Gove Ct., Mason OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGW

Trailing 12 months
1 clearance under product code GGW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GGW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260