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FDA 510(k)

HYBRITECH 405-500 NM FILTER MODULE

K-Number: K832397 · 1983-08-31

ApplicantHybritech, Inc.
Decision Date1983-08-31
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYBRITECH 405-500 NM FILTER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K832397. 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 HYBRITECH 405-500 NM FILTER MODULE?

HYBRITECH 405-500 NM FILTER MODULE is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Hybritech, Inc.. The 510(k) number is K832397.

When did HYBRITECH 405-500 NM FILTER MODULE receive FDA 510(k) clearance?

HYBRITECH 405-500 NM FILTER MODULE received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832397.

Who is the listed applicant for HYBRITECH 405-500 NM FILTER MODULE?

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

What is the FDA product code for HYBRITECH 405-500 NM FILTER MODULE?

The FDA product code for HYBRITECH 405-500 NM FILTER MODULE is JJQ.

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Other records listing Hybritech, 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

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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.

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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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