510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973212Substantially Equivalent

Fresh Cells Wi-38

Ortho-Clinical Diagnostics, Inc., Athens OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973212 is the FDA 510(k) clearance record for FRESH CELLS WI-38, a class I device, cleared for Diagnostic Hybrids, Inc. on under FDA product code KIR (Cells, Animal And Human, Cultured). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K973212.

Clearance record

Decision date
Received
(29 days to decision)
Product code
KIR Cells, Animal And Human, Cultured
Regulation
21 CFR 864.2280
Device class
Class I
Review panel
Hematology
Applicant
Diagnostic Hybrids, Inc. One President St., Athens OH
510(k) summary
Summary
Third party review
No

Clearances, product code KIR

Trailing 12 months

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

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