510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885138Substantially Equivalent

Capillary Tube, Blood Collection

Coeur Laboratories, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885138 is the FDA 510(k) clearance record for CAPILLARY TUBE, BLOOD COLLECTION, a class I device, cleared for Coeur Laboratories, Inc. on under FDA product code GIO (Tube, Collection, Capillary Blood). FDA records list 10 510(k) clearances for Coeur Laboratories, Inc., from to . As of , FDA records show no recalls naming K885138.

Clearance record

Decision date
Received
(54 days to decision)
Product code
GIO Tube, Collection, Capillary Blood
Regulation
21 CFR 864.6150
Device class
Class I
Review panel
Hematology
Applicant
Coeur Laboratories, Inc. 5301 Depature Dr., Raleigh NC
Third party review
No

Clearances, product code GIO

Trailing 12 months

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

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