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FDA 510(k)

GENETIC SYSTEMS MICROPLATE READER

K-Number: K891767 · 1989-07-25

ApplicantGenetic Systems Corp.
Decision Date1989-07-25
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENETIC SYSTEMS MICROPLATE READER is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Systems Corp.. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K891767. 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 GENETIC SYSTEMS MICROPLATE READER?

GENETIC SYSTEMS MICROPLATE READER is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Genetic Systems Corp.. The 510(k) number is K891767.

When did GENETIC SYSTEMS MICROPLATE READER receive FDA 510(k) clearance?

GENETIC SYSTEMS MICROPLATE READER received FDA 510(k) clearance on 1989-07-25, under 510(k) number K891767.

Who is the listed applicant for GENETIC SYSTEMS MICROPLATE READER?

The FDA 510(k) record lists Genetic Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENETIC SYSTEMS MICROPLATE READER?

The FDA product code for GENETIC SYSTEMS MICROPLATE READER is JJQ.

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Other records listing Genetic Systems Corp. 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.

K891766GENETIC SYSTEMS MICROPLATE STRIP WASHERK891768GENETIC SYSTEMS MICROPLATE WASHERK891765GENETIC SYSTEMS PIPETTOR/DILUTORK890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITK873564GENETIC SYSTEMS RSV REAGENT CONTROL SLIDESK873542MICROPLATE AUTO-WASHER (MOTORIZED STAGE)

View all 12 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.

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