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FDA 510(k)

DILUTION SPIKE

K-Number: K780209 · 1978-04-10

ApplicantSterling Drug, Inc.
Decision Date1978-04-10
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DILUTION SPIKE is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Drug, Inc.. It received FDA 510(k) clearance on 1978-04-10 under 510(k) number K780209. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILUTION SPIKE?

DILUTION SPIKE is a medical device that received FDA 510(k) clearance on 1978-04-10. The listed applicant is Sterling Drug, Inc.. The 510(k) number is K780209.

When did DILUTION SPIKE receive FDA 510(k) clearance?

DILUTION SPIKE received FDA 510(k) clearance on 1978-04-10, under 510(k) number K780209.

Who is the listed applicant for DILUTION SPIKE?

The FDA 510(k) record lists Sterling Drug, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DILUTION SPIKE?

The FDA product code for DILUTION SPIKE is FMI.

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Related Devices (Code: FMI)

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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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