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FDA 510(k)

LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)

K-Number: K853261 · 1985-08-22

ApplicantBehring Diagnostics, Inc.
Decision Date1985-08-22
Product CodeCZS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LASER RBP LASER(RETINOL BINDING PROTEIN 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 1985-08-22 under 510(k) number K853261. The device is classified under product code CZS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)?

LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) is a medical device that received FDA 510(k) clearance on 1985-08-22. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K853261.

When did LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) receive FDA 510(k) clearance?

LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) received FDA 510(k) clearance on 1985-08-22, under 510(k) number K853261.

Who is the listed applicant for LASER RBP LASER(RETINOL BINDING PROTEIN 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 RBP LASER(RETINOL BINDING PROTEIN REAGENTS)?

The FDA product code for LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) is CZS.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: CZS)

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.

K973189RETINOL BINDING PROTEIN RBP RID KITThe Binding Site, Ltd.K955881RETINOL BINDING RID KITThe Binding Site, 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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