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FDA 510(k)

EMIT IIC NEGATIVE CONTROL, CONTROL I AND II

K-Number: K935230 · 1994-01-03

ApplicantSyva Co.
Decision Date1994-01-03
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT IIC NEGATIVE CONTROL, CONTROL I AND II is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1994-01-03 under 510(k) number K935230. 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 IIC NEGATIVE CONTROL, CONTROL I AND II?

EMIT IIC NEGATIVE CONTROL, CONTROL I AND II is a medical device that received FDA 510(k) clearance on 1994-01-03. The listed applicant is Syva Co.. The 510(k) number is K935230.

When did EMIT IIC NEGATIVE CONTROL, CONTROL I AND II receive FDA 510(k) clearance?

EMIT IIC NEGATIVE CONTROL, CONTROL I AND II received FDA 510(k) clearance on 1994-01-03, under 510(k) number K935230.

Who is the listed applicant for EMIT IIC NEGATIVE CONTROL, CONTROL I AND II?

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 IIC NEGATIVE CONTROL, CONTROL I AND II?

The FDA product code for EMIT IIC NEGATIVE CONTROL, CONTROL I AND II is DIF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Syva Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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