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FDA 510(k)

PHOTON IMMUNOASSAY ANALYZER

K-Number: K832364 · 1983-08-26

ApplicantHybritech, Inc.
Decision Date1983-08-26
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOTON IMMUNOASSAY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1983-08-26 under 510(k) number K832364. 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 PHOTON IMMUNOASSAY ANALYZER?

PHOTON IMMUNOASSAY ANALYZER is a medical device that received FDA 510(k) clearance on 1983-08-26. The listed applicant is Hybritech, Inc.. The 510(k) number is K832364.

When did PHOTON IMMUNOASSAY ANALYZER receive FDA 510(k) clearance?

PHOTON IMMUNOASSAY ANALYZER received FDA 510(k) clearance on 1983-08-26, under 510(k) number K832364.

Who is the listed applicant for PHOTON IMMUNOASSAY ANALYZER?

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 PHOTON IMMUNOASSAY ANALYZER?

The FDA product code for PHOTON IMMUNOASSAY ANALYZER 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.

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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