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FDA 510(k)

RFA-300 RAPID FLOW ANALYZER W/COMPUTER

K-Number: K851542 · 1985-05-10

ApplicantAlpkem Corp.
Decision Date1985-05-10
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RFA-300 RAPID FLOW ANALYZER W/COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-05-10 under 510(k) number K851542. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RFA-300 RAPID FLOW ANALYZER W/COMPUTER?

RFA-300 RAPID FLOW ANALYZER W/COMPUTER is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Alpkem Corp.. The 510(k) number is K851542.

When did RFA-300 RAPID FLOW ANALYZER W/COMPUTER receive FDA 510(k) clearance?

RFA-300 RAPID FLOW ANALYZER W/COMPUTER received FDA 510(k) clearance on 1985-05-10, under 510(k) number K851542.

Who is the listed applicant for RFA-300 RAPID FLOW ANALYZER W/COMPUTER?

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

What is the FDA product code for RFA-300 RAPID FLOW ANALYZER W/COMPUTER?

The FDA product code for RFA-300 RAPID FLOW ANALYZER W/COMPUTER is JJF.

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Other records listing Alpkem Corp. as applicant

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Related Devices (Code: JJF)

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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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