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FDA 510(k)

ECLIPSE ICA ANALYZER

K-Number: K910302 · 1991-02-22

ApplicantBiotope, Inc.
Decision Date1991-02-22
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ECLIPSE ICA ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Biotope, Inc.. It received FDA 510(k) clearance on 1991-02-22 under 510(k) number K910302. 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 ECLIPSE ICA ANALYZER?

ECLIPSE ICA ANALYZER is a medical device that received FDA 510(k) clearance on 1991-02-22. The listed applicant is Biotope, Inc.. The 510(k) number is K910302.

When did ECLIPSE ICA ANALYZER receive FDA 510(k) clearance?

ECLIPSE ICA ANALYZER received FDA 510(k) clearance on 1991-02-22, under 510(k) number K910302.

Who is the listed applicant for ECLIPSE ICA ANALYZER?

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

What is the FDA product code for ECLIPSE ICA ANALYZER?

The FDA product code for ECLIPSE ICA ANALYZER is JJQ.

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Other records listing Biotope, 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.

K905145ECLIPSE ICA CHOLESTEROLK910256ECLIPSE ICA TSHK905601ECLIPSE ICA TRIGLYCERIDESK905719ECLIPSE ICA DIGOXINK905602ECLIPSE ICA BUNK905144ECLIPSE ICA GLUCOSE

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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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