510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990664Substantially Equivalent

Prima System - Old, Bartels Elisa - New

Intracel Corp., Rockville MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K990664 is the FDA 510(k) clearance record for PRIMA SYSTEM - OLD, BARTELS ELISA - NEW, a class I device, cleared for Intracel Corp. on under FDA product code LLH (Reagents, Clostridium Difficile Toxin). FDA records list 5 510(k) clearances for Intracel Corp., from to . As of , FDA records show no recalls naming K990664.

Clearance record

Decision date
Received
(30 days to decision)
Product code
LLH Reagents, Clostridium Difficile Toxin
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Intracel Corp. 1330 Piccard Dr., Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code LLH

Trailing 12 months

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

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