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FDA 510(k)

URINE NEGATIVE CALIBRATOR

K-Number: K790400 · 1979-06-15

ApplicantSyva Co.
Decision Date1979-06-15
Product CodeDLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

URINE NEGATIVE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1979-06-15 under 510(k) number K790400. The device is classified under product code DLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE NEGATIVE CALIBRATOR?

URINE NEGATIVE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1979-06-15. The listed applicant is Syva Co.. The 510(k) number is K790400.

When did URINE NEGATIVE CALIBRATOR receive FDA 510(k) clearance?

URINE NEGATIVE CALIBRATOR received FDA 510(k) clearance on 1979-06-15, under 510(k) number K790400.

Who is the listed applicant for URINE NEGATIVE CALIBRATOR?

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 URINE NEGATIVE CALIBRATOR?

The FDA product code for URINE NEGATIVE CALIBRATOR is DLT.

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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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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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