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FDA 510(k)

OPUS BONE ALP

K-Number: K964764 · 1997-01-24

ApplicantBehring Diagnostics, Inc.
Decision Date1997-01-24
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS BONE ALP 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 1997-01-24 under 510(k) number K964764. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS BONE ALP?

OPUS BONE ALP is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K964764.

When did OPUS BONE ALP receive FDA 510(k) clearance?

OPUS BONE ALP received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964764.

Who is the listed applicant for OPUS BONE ALP?

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 OPUS BONE ALP?

The FDA product code for OPUS BONE ALP is CIN.

Other records listing Behring Diagnostics, 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

View all 145 devices →

Related Devices (Code: CIN)

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.

K232904Access OstaseBeckman CoulterK200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OYK020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena LaboratoriesK011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)SebiaK994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, 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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