510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912201Substantially Equivalent

Packs-4 (Tm) Analyzer

Helena Laboratories, Corp., Beaumont TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912201 is the FDA 510(k) clearance record for PACKS-4 (TM) ANALYZER, a class II device, cleared for Helena Laboratories on under FDA product code JBY (Aggregometer, Platelet, Photo-Optical Scanning). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K912201.

Clearance record

Decision date
Received
(88 days to decision)
Product code
JBY Aggregometer, Platelet, Photo-Optical Scanning
Regulation
21 CFR 864.6675
Device class
Class II
Review panel
Hematology
Applicant
Helena Laboratories 1530 Lindbergh Dr., Beaumont TX
510(k) summary
Statement
Third party review
No

Clearances, product code JBY

Trailing 12 months

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

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