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FDA 510(k)

LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)

K-Number: K852247 · 1985-07-10

ApplicantBehring Diagnostics, Inc.
Decision Date1985-07-10
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-07-10 under 510(k) number K852247. The device is classified under product code DDB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)?

LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) is a medical device that received FDA 510(k) clearance on 1985-07-10. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K852247.

When did LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) receive FDA 510(k) clearance?

LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) received FDA 510(k) clearance on 1985-07-10, under 510(k) number K852247.

Who is the listed applicant for LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)?

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

What is the FDA product code for LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)?

The FDA product code for LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) is DDB.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: DDB)

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.

K161508CeruloplasminBeckman Coulter Ireland, Inc.K122965HUMAN CAERULOPLASMIN KITThe Binding Site Group , Ltd.K053074N ANTISERA TO HUMAN CERULOPLASMINDade Behring, Inc.K964762IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTBeckman Instruments, Inc.K913668CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K895377QM300 CERULOPLASMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, 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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