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FDA 510(k)

FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST

K-Number: K931557 · 1994-03-11

ApplicantFuller Laboratories, Inc.
Decision Date1994-03-11
Product CodeGRZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST is the device name listed in this FDA 510(k) record. The listed applicant is Fuller Laboratories, Inc.. It received FDA 510(k) clearance on 1994-03-11 under 510(k) number K931557. The device is classified under product code GRZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST?

FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Fuller Laboratories, Inc.. The 510(k) number is K931557.

When did FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST receive FDA 510(k) clearance?

FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST received FDA 510(k) clearance on 1994-03-11, under 510(k) number K931557.

Who is the listed applicant for FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST?

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

What is the FDA product code for FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST?

The FDA product code for FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST is GRZ.

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Other records listing Fuller Laboratories, Inc. as applicant

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Related Devices (Code: GRZ)

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.

K946373MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEMZeus Scientific, Inc.K944417ZEUA MYCOPLASMAZeus Scientific, Inc.K861716FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODYWhittaker Bioproducts, Inc.K840012INDIRECT FLUORESCENT ANTIBODY MYCOZeus Technologies

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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