510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771953Substantially Equivalent

Gastrin Ria Module

Inter Science Institute, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771953 is the FDA 510(k) clearance record for GASTRIN RIA MODULE, a class I device, cleared for Inter Science Institute on under FDA product code CGC (Radioimmunoassay, Gastrin). FDA records list 3 510(k) clearances for Inter Science Institute. As of , FDA records show no recalls naming K771953.

Clearance record

Decision date
Received
(95 days to decision)
Product code
CGC Radioimmunoassay, Gastrin
Regulation
21 CFR 862.1325
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Inter Science Institute 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CGC

Trailing 12 months

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

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