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FDA 510(k)

ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.

K-Number: K761236 · 1976-12-30

ApplicantBehring Diagnostics, Inc.
Decision Date1976-12-30
Product CodeJZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. 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 1976-12-30 under 510(k) number K761236. The device is classified under product code JZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.?

ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K761236.

When did ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. receive FDA 510(k) clearance?

ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761236.

Who is the listed applicant for ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.?

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 ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.?

The FDA product code for ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. is JZW.

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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

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Related Devices (Code: JZW)

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.

K001647BN PROSPEC SYSTEMDade Behring, Inc.K761234BEHRING LASER NEPHELOMETERBehring Diagnostics, Inc.K892223BEHRING NEPHELOMETER 100Behring Diagnostics, Inc.K873407RRT SYSTEM LASER REFLECTOMETER ANALYZERIncstar Corp.K873401TURBOXUnipath , Ltd.K801949BCM-302 COLLIMATING CONE & COMPENSATINB C Medical , Ltd.

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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