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FDA 510(k)

BIOTRACK APTT CONTROLS

K-Number: K890051 · 1989-02-23

ApplicantBiotrack, Inc.
Decision Date1989-02-23
Product CodeGIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOTRACK APTT CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1989-02-23 under 510(k) number K890051. The device is classified under product code GIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACK APTT CONTROLS?

BIOTRACK APTT CONTROLS is a medical device that received FDA 510(k) clearance on 1989-02-23. The listed applicant is Biotrack, Inc.. The 510(k) number is K890051.

When did BIOTRACK APTT CONTROLS receive FDA 510(k) clearance?

BIOTRACK APTT CONTROLS received FDA 510(k) clearance on 1989-02-23, under 510(k) number K890051.

Who is the listed applicant for BIOTRACK APTT CONTROLS?

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

What is the FDA product code for BIOTRACK APTT CONTROLS?

The FDA product code for BIOTRACK APTT CONTROLS is GIT.

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Other records listing Biotrack, 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.

K934061BIOTRACK VALPROIC ACID TEST CARTRIDGEK934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLSK920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLK915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEK915755BIOTRACK PHENYTOIN TEST CARTRIDGEK903924BIOTRACK THEOPHYLLINE QUALITY CONTROLS

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Related Devices (Code: GIT)

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.

K881999PLATELIN(R) EXCEL LOrganon Teknika Corp.K880711CLP 0.02 M CALCIUM CHLORIDE SOLUTION.Creative Laboratory Products, Inc.K820450THROMBOSCREENPacific Hemostasis

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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