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FDA 510(k)

SERATEST ENA [SS-B] KIT

K-Number: K862700 · 1986-08-19

ApplicantHemagen Diagnostics, Inc.
Decision Date1986-08-19
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERATEST ENA [SS-B] KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862700. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERATEST ENA [SS-B] KIT?

SERATEST ENA [SS-B] KIT is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K862700.

When did SERATEST ENA [SS-B] KIT receive FDA 510(k) clearance?

SERATEST ENA [SS-B] KIT received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862700.

Who is the listed applicant for SERATEST ENA [SS-B] KIT?

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

What is the FDA product code for SERATEST ENA [SS-B] KIT?

The FDA product code for SERATEST ENA [SS-B] KIT is LLL.

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Related Devices (Code: LLL)

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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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