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FDA 510(k)

FLUOR-B MEL A DIRECT FLUORESCENT ANTI

K-Number: K833613 · 1983-12-12

ApplicantPetra Biomedical Products, Inc.
Decision Date1983-12-12
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLUOR-B MEL A DIRECT FLUORESCENT ANTI is the device name listed in this FDA 510(k) record. The listed applicant is Petra Biomedical Products, Inc.. It received FDA 510(k) clearance on 1983-12-12 under 510(k) number K833613. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOR-B MEL A DIRECT FLUORESCENT ANTI?

FLUOR-B MEL A DIRECT FLUORESCENT ANTI is a medical device that received FDA 510(k) clearance on 1983-12-12. The listed applicant is Petra Biomedical Products, Inc.. The 510(k) number is K833613.

When did FLUOR-B MEL A DIRECT FLUORESCENT ANTI receive FDA 510(k) clearance?

FLUOR-B MEL A DIRECT FLUORESCENT ANTI received FDA 510(k) clearance on 1983-12-12, under 510(k) number K833613.

Who is the listed applicant for FLUOR-B MEL A DIRECT FLUORESCENT ANTI?

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

What is the FDA product code for FLUOR-B MEL A DIRECT FLUORESCENT ANTI?

The FDA product code for FLUOR-B MEL A DIRECT FLUORESCENT ANTI is JSS.

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Other records listing Petra Biomedical Products, 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.

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Related Devices (Code: JSS)

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

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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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