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FDA 510(k)

CANDIDATE(R) SUPER

K-Number: K863499 · 1987-03-19

ApplicantMercia Diagnostics , Ltd.
Decision Date1987-03-19
Product CodeLRF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CANDIDATE(R) SUPER is the device name listed in this FDA 510(k) record. The listed applicant is Mercia Diagnostics , Ltd.. It received FDA 510(k) clearance on 1987-03-19 under 510(k) number K863499. The device is classified under product code LRF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDIDATE(R) SUPER?

CANDIDATE(R) SUPER is a medical device that received FDA 510(k) clearance on 1987-03-19. The listed applicant is Mercia Diagnostics , Ltd.. The 510(k) number is K863499.

When did CANDIDATE(R) SUPER receive FDA 510(k) clearance?

CANDIDATE(R) SUPER received FDA 510(k) clearance on 1987-03-19, under 510(k) number K863499.

Who is the listed applicant for CANDIDATE(R) SUPER?

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

What is the FDA product code for CANDIDATE(R) SUPER?

The FDA product code for CANDIDATE(R) SUPER is LRF.

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Other records listing Mercia Diagnostics , Ltd. 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.

K915479CAPTIA CMV-TAK904524CAPTIA(R) SYPHILIS M, MODIFICATIONK900654MODIFIED CAPTIA(R) SYPHILIS-MK896295CAPTIA(R) CMV-MK900655MODIFIED CAPTIA(R) TOXO-MK896194CAPTIA(R) CMV-G

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Related Devices (Code: LRF)

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.

K883118ON THE SPOT CANDIDASUREMedi-Tech, Inc.K843286EI-CANDIDA ENZYME IMMUNOASSAY EI1001Immuno-Mycologics, 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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