FDA 510(k)

EMIT-ST URINE CONTROLS SET A #3A349

K-Number: K820462 · 1982-03-11

Decision Date1982-03-11

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

EMIT-ST URINE CONTROLS SET A #3A349 is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-03-11 under 510(k) number K820462. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT-ST URINE CONTROLS SET A #3A349?

EMIT-ST URINE CONTROLS SET A #3A349 is a medical device that received FDA 510(k) clearance on 1982-03-11. The listed applicant is Syva Co.. The 510(k) number is K820462.

When did EMIT-ST URINE CONTROLS SET A #3A349 receive FDA 510(k) clearance?

EMIT-ST URINE CONTROLS SET A #3A349 received FDA 510(k) clearance on 1982-03-11, under 510(k) number K820462.

Who is the listed applicant for EMIT-ST URINE CONTROLS SET A #3A349?

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

What is the FDA product code for EMIT-ST URINE CONTROLS SET A #3A349?

The FDA product code for EMIT-ST URINE CONTROLS SET A #3A349 is DIF.

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Related Devices (Code: DIF)

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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.