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FDA 510(k)

BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)

K-Number: K860720 · 1986-05-23

ApplicantBiotrack, Inc.
Decision Date1986-05-23
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K860720. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)?

BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Biotrack, Inc.. The 510(k) number is K860720.

When did BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) receive FDA 510(k) clearance?

BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) received FDA 510(k) clearance on 1986-05-23, under 510(k) number K860720.

Who is the listed applicant for BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)?

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 MONITOR (BIOTRACK REAGENT CARTRIDGES)?

The FDA product code for BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) is JJQ.

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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. CONTROLK915755BIOTRACK PHENYTOIN TEST CARTRIDGEK915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEK903924BIOTRACK THEOPHYLLINE QUALITY CONTROLS

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Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, 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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