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FDA 510(k)

POLYCHACO FIA-ABS TEST FOR SYPHILIS

K-Number: K831296 · 1983-07-26

ApplicantParasitic Disease Consultants
Decision Date1983-07-26
Product CodeJWL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

POLYCHACO FIA-ABS TEST FOR SYPHILIS is the device name listed in this FDA 510(k) record. The listed applicant is Parasitic Disease Consultants. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K831296. The device is classified under product code JWL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYCHACO FIA-ABS TEST FOR SYPHILIS?

POLYCHACO FIA-ABS TEST FOR SYPHILIS is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Parasitic Disease Consultants. The 510(k) number is K831296.

When did POLYCHACO FIA-ABS TEST FOR SYPHILIS receive FDA 510(k) clearance?

POLYCHACO FIA-ABS TEST FOR SYPHILIS received FDA 510(k) clearance on 1983-07-26, under 510(k) number K831296.

Who is the listed applicant for POLYCHACO FIA-ABS TEST FOR SYPHILIS?

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

What is the FDA product code for POLYCHACO FIA-ABS TEST FOR SYPHILIS?

The FDA product code for POLYCHACO FIA-ABS TEST FOR SYPHILIS is JWL.

Related Clinical Trials

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.

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Other records listing Parasitic Disease Consultants 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.

K830870POLYCHACO INDIRECT HEMAGGLUTINATIONK830869POLYCHACO INDIRECT IMMUNOFLUORESCENCE

Related Devices (Code: JWL)

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.

K801959FTA-ABS TESTImmuno-Diagnostic Products, Inc.K802276FTA-ABS BIOPAKBioware ProductsK801928LAB-TEK FTA-ABS KITMiles Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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