510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011855Substantially Equivalent

Wampole Hs-Crp Elisa

Carter-Wallace, Inc., Cranbury NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011855 is the FDA 510(k) clearance record for WAMPOLE HS-CRP ELISA, a class II device, cleared for Carter-Wallace, Inc. on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list one 510(k) clearance for Carter-Wallace, Inc. As of , FDA records show no recalls naming K011855.

Clearance record

Decision date
Received
(209 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Carter-Wallace, Inc. P.O. Box 1001, Half Acre Rd., Cranbury NJ
510(k) summary
Summary
Third party review
No

Clearances, product code DCN

Trailing 12 months

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

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