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FDA 510(k)

BIOTRACK ALT TEST CARTRIDGE

K-Number: K895128 · 1989-10-06

ApplicantBiotrack, Inc.
Decision Date1989-10-06
Product CodeCJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTRACK ALT TEST CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K895128. The device is classified under product code CJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACK ALT TEST CARTRIDGE?

BIOTRACK ALT TEST CARTRIDGE is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Biotrack, Inc.. The 510(k) number is K895128.

When did BIOTRACK ALT TEST CARTRIDGE receive FDA 510(k) clearance?

BIOTRACK ALT TEST CARTRIDGE received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895128.

Who is the listed applicant for BIOTRACK ALT TEST CARTRIDGE?

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 ALT TEST CARTRIDGE?

The FDA product code for BIOTRACK ALT TEST CARTRIDGE is CJJ.

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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: CJJ)

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.

K943003CALCIUM QVETPrisma Systems

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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