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FDA 510(k)

OCEAN SCIENTIFIC VDRL TEST

K-Number: K864731 · 1987-03-10

ApplicantOcean Scientific, Inc.
Decision Date1987-03-10
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OCEAN SCIENTIFIC VDRL TEST 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 1987-03-10 under 510(k) number K864731. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCEAN SCIENTIFIC VDRL TEST?

OCEAN SCIENTIFIC VDRL TEST is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Ocean Scientific, Inc.. The 510(k) number is K864731.

When did OCEAN SCIENTIFIC VDRL TEST receive FDA 510(k) clearance?

OCEAN SCIENTIFIC VDRL TEST received FDA 510(k) clearance on 1987-03-10, under 510(k) number K864731.

Who is the listed applicant for OCEAN SCIENTIFIC VDRL TEST?

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 OCEAN SCIENTIFIC VDRL TEST?

The FDA product code for OCEAN SCIENTIFIC VDRL TEST is GMQ.

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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 ANALYZERK863976OCEAN SCIENTIFIC VACUTESTK860987MINI-CHEM ANALYZERK840340CHEM-STAT ANALYZER

Related Devices (Code: GMQ)

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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