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FDA 510(k)

ORIGEN ANALYZER

K-Number: K962166 · 1996-07-31

ApplicantIgen, Inc.
Decision Date1996-07-31
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORIGEN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Igen, Inc.. It received FDA 510(k) clearance on 1996-07-31 under 510(k) number K962166. 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 ORIGEN ANALYZER?

ORIGEN ANALYZER is a medical device that received FDA 510(k) clearance on 1996-07-31. The listed applicant is Igen, Inc.. The 510(k) number is K962166.

When did ORIGEN ANALYZER receive FDA 510(k) clearance?

ORIGEN ANALYZER received FDA 510(k) clearance on 1996-07-31, under 510(k) number K962166.

Who is the listed applicant for ORIGEN ANALYZER?

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

What is the FDA product code for ORIGEN ANALYZER?

The FDA product code for ORIGEN ANALYZER is JJQ.

Related Clinical Trials

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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