510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821977Substantially Equivalent

Gramstain Set

Granite Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821977 is the FDA 510(k) clearance record for GRAMSTAIN SET, a class I device, cleared for Granite Diagnostics, Inc. on under FDA product code HYI (Iodine, Grams). FDA records list 47 510(k) clearances for Granite Diagnostics, Inc., from to . As of , FDA records show no recalls naming K821977.

Clearance record

Decision date
Received
(16 days to decision)
Product code
HYI Iodine, Grams
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Granite Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HYI

Trailing 12 months

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

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