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FDA 510(k)

REPLACEMENT REAGENTS FOR SMAC II SYSTEMS

K-Number: K852306 · 1985-08-02

ApplicantMethodist Hospital of Memphis
Decision Date1985-08-02
Product CodeJJC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REPLACEMENT REAGENTS FOR SMAC II SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Methodist Hospital of Memphis. It received FDA 510(k) clearance on 1985-08-02 under 510(k) number K852306. The device is classified under product code JJC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPLACEMENT REAGENTS FOR SMAC II SYSTEMS?

REPLACEMENT REAGENTS FOR SMAC II SYSTEMS is a medical device that received FDA 510(k) clearance on 1985-08-02. The listed applicant is Methodist Hospital of Memphis. The 510(k) number is K852306.

When did REPLACEMENT REAGENTS FOR SMAC II SYSTEMS receive FDA 510(k) clearance?

REPLACEMENT REAGENTS FOR SMAC II SYSTEMS received FDA 510(k) clearance on 1985-08-02, under 510(k) number K852306.

Who is the listed applicant for REPLACEMENT REAGENTS FOR SMAC II SYSTEMS?

The FDA 510(k) record lists Methodist Hospital of Memphis as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPLACEMENT REAGENTS FOR SMAC II SYSTEMS?

The FDA product code for REPLACEMENT REAGENTS FOR SMAC II SYSTEMS is JJC.

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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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