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FDA 510(k)

SPECTRUM-10

K-Number: K831655 · 1983-06-17

ApplicantAustin Biological Laboratories
Decision Date1983-06-17
Product CodeJSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPECTRUM-10 is the device name listed in this FDA 510(k) record. The listed applicant is Austin Biological Laboratories. It received FDA 510(k) clearance on 1983-06-17 under 510(k) number K831655. The device is classified under product code JSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM-10?

SPECTRUM-10 is a medical device that received FDA 510(k) clearance on 1983-06-17. The listed applicant is Austin Biological Laboratories. The 510(k) number is K831655.

When did SPECTRUM-10 receive FDA 510(k) clearance?

SPECTRUM-10 received FDA 510(k) clearance on 1983-06-17, under 510(k) number K831655.

Who is the listed applicant for SPECTRUM-10?

The FDA 510(k) record lists Austin Biological Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRUM-10?

The FDA product code for SPECTRUM-10 is JSZ.

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Other records listing Austin Biological Laboratories 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.

K880511XACT NEISSERIAK874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862446PRECEPT CEFTAZIDIMEK862560PRECEPT CEFTIZOXIME

View all 45 devices →

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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