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FDA 510(k)

CHEM-STAT ANALYZER

K-Number: K840340 · 1984-03-23

ApplicantOcean Scientific, Inc.
Decision Date1984-03-23
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-STAT ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Ocean Scientific, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840340. 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 CHEM-STAT ANALYZER?

CHEM-STAT ANALYZER is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Ocean Scientific, Inc.. The 510(k) number is K840340.

When did CHEM-STAT ANALYZER receive FDA 510(k) clearance?

CHEM-STAT ANALYZER received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840340.

Who is the listed applicant for CHEM-STAT ANALYZER?

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

What is the FDA product code for CHEM-STAT ANALYZER?

The FDA product code for CHEM-STAT ANALYZER is JJQ.

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Other records listing Ocean Scientific, 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.

K893810IMMUNO-WASH AUTOMATED TUBE WASHERK873638MICRO-CHEM ANALYZERK864731OCEAN SCIENTIFIC VDRL TESTK863976OCEAN SCIENTIFIC VACUTESTK860987MINI-CHEM 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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