FDA 510(k)

PHASE II FERRITIN RADIOIMMUNOASSAY KIT

K-Number: K862960 · 1986-08-27

ApplicantMedical & Scientific Designs, Inc.

Decision Date1986-08-27

Product CodeDBF

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

PHASE II FERRITIN RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical & Scientific Designs, Inc.. It received FDA 510(k) clearance on 1986-08-27 under 510(k) number K862960. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHASE II FERRITIN RADIOIMMUNOASSAY KIT?

PHASE II FERRITIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1986-08-27. The listed applicant is Medical & Scientific Designs, Inc.. The 510(k) number is K862960.

When did PHASE II FERRITIN RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

PHASE II FERRITIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1986-08-27, under 510(k) number K862960.

Who is the listed applicant for PHASE II FERRITIN RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Medical & Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASE II FERRITIN RADIOIMMUNOASSAY KIT?

The FDA product code for PHASE II FERRITIN RADIOIMMUNOASSAY KIT is DBF.

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Related Devices (Code: DBF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.