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FDA 510(k)

SMA REFERENCE SERUM 3

K-Number: K770142 · 1977-02-11

ApplicantTechnicon Instruments Corp.
Decision Date1977-02-11
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMA REFERENCE SERUM 3 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 1977-02-11 under 510(k) number K770142. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMA REFERENCE SERUM 3?

SMA REFERENCE SERUM 3 is a medical device that received FDA 510(k) clearance on 1977-02-11. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K770142.

When did SMA REFERENCE SERUM 3 receive FDA 510(k) clearance?

SMA REFERENCE SERUM 3 received FDA 510(k) clearance on 1977-02-11, under 510(k) number K770142.

Who is the listed applicant for SMA REFERENCE SERUM 3?

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 REFERENCE SERUM 3?

The FDA product code for SMA REFERENCE SERUM 3 is JIX.

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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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