510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964297Substantially Equivalent

N-Assay Tia C4 Test Kit

Crestat Diagnostics, Inc., Murrieta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964297 is the FDA 510(k) clearance record for N-ASSAY TIA C4 TEST KIT, a class II device, cleared for Crestat Diagnostics, Inc. on under FDA product code DBI (Complement C4, Antigen, Antiserum, Control). FDA records list 29 510(k) clearances for Crestat Diagnostics, Inc., from to . As of , FDA records show no recalls naming K964297.

Clearance record

Decision date
Received
(258 days to decision)
Product code
DBI Complement C4, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
Device class
Class II
Review panel
Immunology
Applicant
Crestat Diagnostics, Inc. 25549 Adams Ave., Murrieta CA
510(k) summary
Statement
Third party review
No

Clearances, product code DBI

Trailing 12 months

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

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