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FDA 510(k)

QUANTUM II BACTERIAL IDENT. SYSTEM

K-Number: K830698 · 1983-04-08

ApplicantAbbott Laboratories
Decision Date1983-04-08
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUANTUM II BACTERIAL IDENT. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-04-08 under 510(k) number K830698. 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 QUANTUM II BACTERIAL IDENT. SYSTEM?

QUANTUM II BACTERIAL IDENT. SYSTEM is a medical device that received FDA 510(k) clearance on 1983-04-08. The listed applicant is Abbott Laboratories. The 510(k) number is K830698.

When did QUANTUM II BACTERIAL IDENT. SYSTEM receive FDA 510(k) clearance?

QUANTUM II BACTERIAL IDENT. SYSTEM received FDA 510(k) clearance on 1983-04-08, under 510(k) number K830698.

Who is the listed applicant for QUANTUM II BACTERIAL IDENT. SYSTEM?

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

What is the FDA product code for QUANTUM II BACTERIAL IDENT. SYSTEM?

The FDA product code for QUANTUM II BACTERIAL IDENT. SYSTEM is JSS.

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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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