FDA 510(k)

SHBG IRMA KIT

K-Number: K861679 · 1987-03-13

Decision Date1987-03-13

Product CodeCDZ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SHBG IRMA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Farmos Group , Ltd.. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K861679. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHBG IRMA KIT?

SHBG IRMA KIT is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Farmos Group , Ltd.. The 510(k) number is K861679.

When did SHBG IRMA KIT receive FDA 510(k) clearance?

SHBG IRMA KIT received FDA 510(k) clearance on 1987-03-13, under 510(k) number K861679.

Who is the listed applicant for SHBG IRMA KIT?

The FDA 510(k) record lists Farmos Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHBG IRMA KIT?

The FDA product code for SHBG IRMA KIT is CDZ.

Related Devices (Code: CDZ)

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.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems Limited K240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited K233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche Diagnostics K201908LIAISON Testosterone xtDiaSorin, 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.