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

Tube, Collection, Capillary Blood

21 CFR 864.6150 / Hematology
FDA source (opens on fda.gov)

GIO is the FDA product code for Tube, Collection, Capillary Blood, a class I device type, regulated under 21 CFR 864.6150. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 25 recalls.

Classification record

Product code
GIO
Device name
Tube, Collection, Capillary Blood
Regulation
21 CFR 864.6150
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
22
Ingested recalls
25

Clearances, product code GIO

By decision year
22 clearances under product code GIO with a decision year between 1977 and 1997, 1981 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GIO by decision year
YearClearances
19771
19815
19831
19844
19851
19871
19884
19893
19941
19971

Applicants with the most clearances

Product code GIO
Applicants holding the most 510(k) clearances under product code GIO
ApplicantClearances
American Dade5
Medical Technomics, Ltd.3
Sherwood Medical Co.3
Helps Products, Inc.2
Abco Dealers, Inc.1
Coeur Laboratories, Inc.1
Corning Medical & Scientific1
Humagen, Inc.1
Innovative Medical Technologies, Inc1
Medical Products Search, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order