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FDA 510(k)

LEECO VIS-DISK STREP-A (EIA)

K-Number: K894122 · 1989-08-15

ApplicantLeeco Diagnostics, Inc.
Decision Date1989-08-15
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEECO VIS-DISK STREP-A (EIA) is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K894122. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEECO VIS-DISK STREP-A (EIA)?

LEECO VIS-DISK STREP-A (EIA) is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K894122.

When did LEECO VIS-DISK STREP-A (EIA) receive FDA 510(k) clearance?

LEECO VIS-DISK STREP-A (EIA) received FDA 510(k) clearance on 1989-08-15, under 510(k) number K894122.

Who is the listed applicant for LEECO VIS-DISK STREP-A (EIA)?

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

What is the FDA product code for LEECO VIS-DISK STREP-A (EIA)?

The FDA product code for LEECO VIS-DISK STREP-A (EIA) is GTZ.

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Other records listing Leeco Diagnostics, Inc. 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.

K895765LEECO PREVIEW(R) EBV (EIA)K891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MK891096VIS-DISK HCG (EIA) JPL-041MK883269PRL-QUANTK880577CONCEP-7-BHCGK880069LEECO PREGNASTICK (EIA) CATALOG #003

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Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, Inc.

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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