510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842277Substantially Equivalent

Dimertest Latex

Mabco, Inc., Springwood Qld 4127 Austr, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842277 is the FDA 510(k) clearance record for DIMERTEST LATEX, a class II device, cleared for Mabco, Inc. on under FDA product code GHH (Fibrin Split Products). FDA records list one 510(k) clearance for Mabco, Inc. As of , FDA records show no recalls naming K842277.

Clearance record

Decision date
Received
(299 days to decision)
Product code
GHH Fibrin Split Products
Regulation
21 CFR 864.7320
Device class
Class II
Review panel
Hematology
Applicant
Mabco, Inc. P.O. Box 475, Springwood Qld 4127 Austr, AT
Third party review
No

Clearances, product code GHH

Trailing 12 months

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

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