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FDA 510(k)

STREPTEX ZL01

K-Number: K842828 · 1984-08-15

ApplicantWellcome Diagnostics
Decision Date1984-08-15
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREPTEX ZL01 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1984-08-15 under 510(k) number K842828. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREPTEX ZL01?

STREPTEX ZL01 is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Wellcome Diagnostics. The 510(k) number is K842828.

When did STREPTEX ZL01 receive FDA 510(k) clearance?

STREPTEX ZL01 received FDA 510(k) clearance on 1984-08-15, under 510(k) number K842828.

Who is the listed applicant for STREPTEX ZL01?

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

What is the FDA product code for STREPTEX ZL01?

The FDA product code for STREPTEX ZL01 is JTO.

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Other records listing Wellcome Diagnostics 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.

K915203D-DIMER WELLCOTEST (HA10)K910797STREPTEX ACID EXTRACTION KITK895461WELLCOLEX COLOUR SHIGELLA TEST ZC51K890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50K875311WELLCOZYME HSV WZO2K861628WELLCOZYME ROTAVIRUS WZ01

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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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