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FDA 510(k)

CAPILLARY TUBE, BLOOD COLLECTION

K-Number: K885138 · 1989-02-07

ApplicantCoeur Laboratories, Inc.
Decision Date1989-02-07
Product CodeGIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CAPILLARY TUBE, BLOOD COLLECTION is the device name listed in this FDA 510(k) record. The listed applicant is Coeur Laboratories, Inc.. It received FDA 510(k) clearance on 1989-02-07 under 510(k) number K885138. The device is classified under product code GIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPILLARY TUBE, BLOOD COLLECTION?

CAPILLARY TUBE, BLOOD COLLECTION is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Coeur Laboratories, Inc.. The 510(k) number is K885138.

When did CAPILLARY TUBE, BLOOD COLLECTION receive FDA 510(k) clearance?

CAPILLARY TUBE, BLOOD COLLECTION received FDA 510(k) clearance on 1989-02-07, under 510(k) number K885138.

Who is the listed applicant for CAPILLARY TUBE, BLOOD COLLECTION?

The FDA 510(k) record lists Coeur Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPILLARY TUBE, BLOOD COLLECTION?

The FDA product code for CAPILLARY TUBE, BLOOD COLLECTION is GIO.

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Other records listing Coeur Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971712COEUR 130 ML ANGIOGRAPHIC SYRINGEK965214COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211K890292PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGEK88520216 LONG CATHETER W/ADAPTER, 14 FR AND 12 FRK881646UROLOGICAL CATHETER

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Related Devices (Code: GIO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972969QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.K941291MONOJECT SAMPLETTE SEPARATOR TUBESherwood Medical Co.K894851TRU-TRAXHumagen, Inc.K885324HEMA(PRO)TEC(TION)Medical Products Search, Inc.K884623SAFE-TEC CAPILLARY BLOOD COLLECTION TUBESafe-Tec Clinical Products, Inc.K881262CARAWAY TUBES, HEPARIN AND PLAINHelps Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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