510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962113Substantially Equivalent

Anthos Phacts Version Microplate Reader

Columbia Bioscience, Inc., Frederick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962113 is the FDA 510(k) clearance record for ANTHOS PHACTS VERSION MICROPLATE READER, a class I device, cleared for Columbia Bioscience, Inc. on under FDA product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use). FDA records list 13 510(k) clearances for Columbia Bioscience, Inc., from to . As of , FDA records show no recalls naming K962113.

Clearance record

Decision date
Received
(158 days to decision)
Product code
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Regulation
21 CFR 862.2300
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Columbia Bioscience, Inc. 182 Thomas Johson Dr., Frederick MD
510(k) summary
Summary
Third party review
No

Clearances, product code JJQ

Trailing 12 months

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

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