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FDA 510(k)

CHEMISTRY ANALYZER, GEN. PURPOSE

K-Number: K842311 · 1984-07-25

ApplicantHml Inc/Biotechnology Transfer
Decision Date1984-07-25
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMISTRY ANALYZER, GEN. PURPOSE is the device name listed in this FDA 510(k) record. The listed applicant is Hml Inc/Biotechnology Transfer. It received FDA 510(k) clearance on 1984-07-25 under 510(k) number K842311. 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 CHEMISTRY ANALYZER, GEN. PURPOSE?

CHEMISTRY ANALYZER, GEN. PURPOSE is a medical device that received FDA 510(k) clearance on 1984-07-25. The listed applicant is Hml Inc/Biotechnology Transfer. The 510(k) number is K842311.

When did CHEMISTRY ANALYZER, GEN. PURPOSE receive FDA 510(k) clearance?

CHEMISTRY ANALYZER, GEN. PURPOSE received FDA 510(k) clearance on 1984-07-25, under 510(k) number K842311.

Who is the listed applicant for CHEMISTRY ANALYZER, GEN. PURPOSE?

The FDA 510(k) record lists Hml Inc/Biotechnology Transfer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEMISTRY ANALYZER, GEN. PURPOSE?

The FDA product code for CHEMISTRY ANALYZER, GEN. PURPOSE 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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Other records listing Hml Inc/Biotechnology Transfer 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.

K843000MICRO ORGANISM GROWTH SYS-M1000K842310HEMATOLOGY ANALYZER

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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