510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812603Substantially Equivalent

Tanarama

Marketing Consultants of America, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812603 is the FDA 510(k) clearance record for TANARAMA, a class II device, cleared for Marketing Consultants of America on under FDA product code GGG (Guaiac Reagent). FDA records list 2 510(k) clearances for Marketing Consultants of America, from to . As of , FDA records show no recalls naming K812603.

Clearance record

Decision date
Received
(66 days to decision)
Product code
GGG Guaiac Reagent
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Marketing Consultants of America 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GGG

Trailing 12 months

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

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