510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952501Substantially Equivalent

Tox Perfect B Tubes and Reagents

Chimera Research & Chemical, Inc., Seminole FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952501 is the FDA 510(k) clearance record for TOX PERFECT B TUBES AND REAGENTS, a class I device, cleared for Chimera Research & Chemical, Inc. on under FDA product code DPM (Columns, Liquid Chromatography). FDA records list 7 510(k) clearances for Chimera Research & Chemical, Inc., from to . As of , FDA records show no recalls naming K952501.

Clearance record

Decision date
Received
(86 days to decision)
Product code
DPM Columns, Liquid Chromatography
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Chimera Research & Chemical, Inc. P.O. Box 3363, Seminole FL
510(k) summary
Statement
Third party review
No

Clearances, product code DPM

Trailing 12 months

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

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