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FDA 510(k)

RUBEOLA TEST

K-Number: K884004 · 1988-12-05

ApplicantGull Laboratories, Inc.
Decision Date1988-12-05
Product CodeGRE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBEOLA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1988-12-05 under 510(k) number K884004. The device is classified under product code GRE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBEOLA TEST?

RUBEOLA TEST is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K884004.

When did RUBEOLA TEST receive FDA 510(k) clearance?

RUBEOLA TEST received FDA 510(k) clearance on 1988-12-05, under 510(k) number K884004.

Who is the listed applicant for RUBEOLA TEST?

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

What is the FDA product code for RUBEOLA TEST?

The FDA product code for RUBEOLA TEST is GRE.

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Other records listing Gull Laboratories, Inc. as applicant

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Related Devices (Code: GRE)

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.

K853067FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENTIdt, A Division of Whittaker M.A. BioproductsK821249ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUSElectro-Nucleonics Laboratories, Inc.K770687MEASLESVIRUS FLOURE. CONJUGATED ANTISERUMicrobiological Assoc.

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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