510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890836Substantially Equivalent

Ria-Gnost Progesterone

Cambridge Medical Technology, Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890836 is the FDA 510(k) clearance record for RIA-GNOST PROGESTERONE, a class I device, cleared for Cambridge Medical Technology on under FDA product code JLS (Radioimmunoassay, Progesterone). FDA records list 14 510(k) clearances for Cambridge Medical Technology, from to . As of , FDA records show no recalls naming K890836.

Clearance record

Decision date
Received
(23 days to decision)
Product code
JLS Radioimmunoassay, Progesterone
Regulation
21 CFR 862.1620
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Cambridge Medical Technology 575 Middlesex Tpke., Billerica MA
Third party review
No

Clearances, product code JLS

Trailing 12 months

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

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