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FDA 510(k)

CLINICAL ANALYZER SYSTEM

K-Number: K780903 · 1978-06-28

ApplicantBausch & Lomb, Inc.
Decision Date1978-06-28
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINICAL ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 1978-06-28 under 510(k) number K780903. 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 CLINICAL ANALYZER SYSTEM?

CLINICAL ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1978-06-28. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K780903.

When did CLINICAL ANALYZER SYSTEM receive FDA 510(k) clearance?

CLINICAL ANALYZER SYSTEM received FDA 510(k) clearance on 1978-06-28, under 510(k) number K780903.

Who is the listed applicant for CLINICAL ANALYZER SYSTEM?

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

What is the FDA product code for CLINICAL ANALYZER SYSTEM?

The FDA product code for CLINICAL ANALYZER SYSTEM is JJQ.

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Other records listing Bausch & Lomb, 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.

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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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