510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K893738Substantially Equivalent

Quidel Reflectance Analyzer

Ortho-Clinical Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893738 is the FDA 510(k) clearance record for QUIDEL REFLECTANCE ANALYZER, a class I device, cleared for Quidel Corp. on under FDA product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K893738.

Clearance record

Decision date
Received
(86 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
Quidel Corp. 10165 Mckellar Ct., San Diego CA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260