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FDA 510(k)

GSC 1000

K-Number: K863566 · 1986-10-16

ApplicantGenetic Systems Corp.
Decision Date1986-10-16
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GSC 1000 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 1986-10-16 under 510(k) number K863566. 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 GSC 1000?

GSC 1000 is a medical device that received FDA 510(k) clearance on 1986-10-16. The listed applicant is Genetic Systems Corp.. The 510(k) number is K863566.

When did GSC 1000 receive FDA 510(k) clearance?

GSC 1000 received FDA 510(k) clearance on 1986-10-16, under 510(k) number K863566.

Who is the listed applicant for GSC 1000?

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 GSC 1000?

The FDA product code for GSC 1000 is JJQ.

Other records listing Genetic Systems Corp. 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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