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FDA 510(k)

SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P

K-Number: K850995 · 1985-05-10

ApplicantAwareness Technology, Inc.
Decision Date1985-05-10
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P 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 1985-05-10 under 510(k) number K850995. 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 SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P?

SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K850995.

When did SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P receive FDA 510(k) clearance?

SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P received FDA 510(k) clearance on 1985-05-10, under 510(k) number K850995.

Who is the listed applicant for SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P?

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 SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P?

The FDA product code for SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P is JJQ.

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Other records listing Awareness Technology, Inc. as applicant

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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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