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FDA 510(k)

SMA II

K-Number: K771336 · 1977-08-26

ApplicantTechnicon Instruments Corp.
Decision Date1977-08-26
Product CodeJJC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMA II is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1977-08-26 under 510(k) number K771336. 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 SMA II?

SMA II is a medical device that received FDA 510(k) clearance on 1977-08-26. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K771336.

When did SMA II receive FDA 510(k) clearance?

SMA II received FDA 510(k) clearance on 1977-08-26, under 510(k) number K771336.

Who is the listed applicant for SMA II?

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

What is the FDA product code for SMA II?

The FDA product code for SMA II is JJC.

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Related Devices (Code: JJC)

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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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