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FDA 510(k)

STAT TRACKS

K-Number: K974762 · 1998-01-28

ApplicantAwareness Technology, Inc.
Decision Date1998-01-28
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT TRACKS is the device name listed in this FDA 510(k) record. The listed applicant is Awareness Technology, Inc.. It received FDA 510(k) clearance on 1998-01-28 under 510(k) number K974762. 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 STAT TRACKS?

STAT TRACKS is a medical device that received FDA 510(k) clearance on 1998-01-28. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K974762.

When did STAT TRACKS receive FDA 510(k) clearance?

STAT TRACKS received FDA 510(k) clearance on 1998-01-28, under 510(k) number K974762.

Who is the listed applicant for STAT TRACKS?

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

What is the FDA product code for STAT TRACKS?

The FDA product code for STAT TRACKS is JJQ.

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Other records listing Awareness Technology, 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.

K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)K013420CHEMWELL, ALSO KNOWN AS PROJECT 2900K010877CHEMWELL, MODEL 2900K943729DYE CHECK STRIPS 545-630K941394STAT FAX 2600K923598REDI-CHECK PHOTMETER Q.A.

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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.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, Inc.K962166ORIGEN ANALYZERIgen, 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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