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FDA 510(k)

PROSPECT MICROPLATE ASSAY

K-Number: K934493 · 1994-09-20

ApplicantAlexon, Inc.
Decision Date1994-09-20
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT MICROPLATE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Alexon, Inc.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K934493. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSPECT MICROPLATE ASSAY?

PROSPECT MICROPLATE ASSAY is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Alexon, Inc.. The 510(k) number is K934493.

When did PROSPECT MICROPLATE ASSAY receive FDA 510(k) clearance?

PROSPECT MICROPLATE ASSAY received FDA 510(k) clearance on 1994-09-20, under 510(k) number K934493.

Who is the listed applicant for PROSPECT MICROPLATE ASSAY?

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

What is the FDA product code for PROSPECT MICROPLATE ASSAY?

The FDA product code for PROSPECT MICROPLATE ASSAY is LLH.

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Other records listing Alexon, 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.

K942098PROSPECT GIARDIAK931147PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATIONK930451PROSPEC T GIARDIA MICROTITER ASSAYK922675PROSPECT GIARDIA CONTROLSK922010PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATIONK920817MODIFICATION PROSPECT GIARDIA RAPID ASSAY

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Related Devices (Code: LLH)

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.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, 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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