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FDA 510(k)

CHLAMYSET ANTIBODY EIA

K-Number: K864457 · 1987-09-11

ApplicantOrion Corp.
Decision Date1987-09-11
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYSET ANTIBODY EIA is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1987-09-11 under 510(k) number K864457. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLAMYSET ANTIBODY EIA?

CHLAMYSET ANTIBODY EIA is a medical device that received FDA 510(k) clearance on 1987-09-11. The listed applicant is Orion Corp.. The 510(k) number is K864457.

When did CHLAMYSET ANTIBODY EIA receive FDA 510(k) clearance?

CHLAMYSET ANTIBODY EIA received FDA 510(k) clearance on 1987-09-11, under 510(k) number K864457.

Who is the listed applicant for CHLAMYSET ANTIBODY EIA?

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

What is the FDA product code for CHLAMYSET ANTIBODY EIA?

The FDA product code for CHLAMYSET ANTIBODY EIA is LJC.

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Other records listing Orion Corp. 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.

K912391RUBALEX, MODIFICATIONK901637RESUBMITTED MODIFIED RUBALEXK884650RESUBMITTED SCANORAK890199DENTOCULT SM-STRIP MUTANSK881506MAMEX DC MAG MG12K881505MAMEX DC MG11

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Related Devices (Code: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, 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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