510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872843Substantially Equivalent

Oveia (Tm) Dual Analyte

Boots-Celltech Diagnostics, Inc., Berkshire, England, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872843 is the FDA 510(k) clearance record for OVEIA (TM) DUAL ANALYTE, a class I device, cleared for Boots-Celltech Diagnostics, Inc. on under FDA product code JLP (Spectrophotometric Method, Pregnanediol). FDA records list 20 510(k) clearances for Boots-Celltech Diagnostics, Inc., from to . As of , FDA records show no recalls naming K872843.

Clearance record

Decision date
Received
(197 days to decision)
Product code
JLP Spectrophotometric Method, Pregnanediol
Regulation
21 CFR 862.1605
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Boots-Celltech Diagnostics, Inc. 240 Bath Rd., Berkshire, England, GB
Third party review
No

Clearances, product code JLP

Trailing 12 months

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

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