510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771201Substantially Equivalent

Formalin Buffer Concentrate

Central Labs. Assoc. MD Pathologists, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771201 is the FDA 510(k) clearance record for FORMALIN BUFFER CONCENTRATE, a class I device, cleared for Central Labs. Assoc. MD Pathologists on under FDA product code IGG (Formaldehyde (Formalin, Formol)). FDA records list 3 510(k) clearances for Central Labs. Assoc. MD Pathologists, from to . As of , FDA records show no recalls naming K771201.

Clearance record

Decision date
Received
(48 days to decision)
Product code
IGG Formaldehyde (Formalin, Formol)
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Central Labs. Assoc. MD Pathologists 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IGG

Trailing 12 months

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

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