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FDA 510(k)

BN PROSPEC SYSTEM

K-Number: K001647 · 2000-09-26

ApplicantDade Behring, Inc.
Decision Date2000-09-26
Product CodeJZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BN PROSPEC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2000-09-26 under 510(k) number K001647. 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 BN PROSPEC SYSTEM?

BN PROSPEC SYSTEM is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Dade Behring, Inc.. The 510(k) number is K001647.

When did BN PROSPEC SYSTEM receive FDA 510(k) clearance?

BN PROSPEC SYSTEM received FDA 510(k) clearance on 2000-09-26, under 510(k) number K001647.

Who is the listed applicant for BN PROSPEC SYSTEM?

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

What is the FDA product code for BN PROSPEC SYSTEM?

The FDA product code for BN PROSPEC SYSTEM is JZW.

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Other records listing Dade Behring, Inc. as applicant

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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.

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.K801391DISC 120 TRANSPORTERTravenol Laboratories, S.A.

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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