510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093297Substantially Equivalent

Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube

Epocal Inc, Ottawa, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093297 is the FDA 510(k) clearance record for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE, a class I device, cleared for Epocal, Inc. on under FDA product code KHP (Acid, Lactic, Enzymatic Method). FDA records list 7 510(k) clearances for Epocal, Inc., from to . As of , FDA records show one recall naming K093297.

Clearance record

Decision date
Received
(231 days to decision)
Product code
KHP Acid, Lactic, Enzymatic Method
Regulation
21 CFR 862.1450
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Epocal, Inc. 2060 Walkley Rd., Ottawa, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHP

Trailing 12 months

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

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