Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STAT FAX(TM)-2100

K-Number: K900224 · 1990-03-01

ApplicantAwareness Technology, Inc.
Decision Date1990-03-01
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT FAX(TM)-2100 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 1990-03-01 under 510(k) number K900224. 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 FAX(TM)-2100?

STAT FAX(TM)-2100 is a medical device that received FDA 510(k) clearance on 1990-03-01. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K900224.

When did STAT FAX(TM)-2100 receive FDA 510(k) clearance?

STAT FAX(TM)-2100 received FDA 510(k) clearance on 1990-03-01, under 510(k) number K900224.

Who is the listed applicant for STAT FAX(TM)-2100?

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 FAX(TM)-2100?

The FDA product code for STAT FAX(TM)-2100 is JJQ.

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 2900K974762STAT TRACKSK943729DYE CHECK STRIPS 545-630K941394STAT FAX 2600

View all 18 devices →

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.

↑