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FDA 510(k)

BIODATA TESTOSTERONE MAIA KIT

K-Number: K955102 · 1996-06-24

ApplicantBiochem Immunosystems (U.S.), Inc.
Decision Date1996-06-24
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIODATA TESTOSTERONE MAIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biochem Immunosystems (U.S.), Inc.. It received FDA 510(k) clearance on 1996-06-24 under 510(k) number K955102. 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 BIODATA TESTOSTERONE MAIA KIT?

BIODATA TESTOSTERONE MAIA KIT is a medical device that received FDA 510(k) clearance on 1996-06-24. The listed applicant is Biochem Immunosystems (U.S.), Inc.. The 510(k) number is K955102.

When did BIODATA TESTOSTERONE MAIA KIT receive FDA 510(k) clearance?

BIODATA TESTOSTERONE MAIA KIT received FDA 510(k) clearance on 1996-06-24, under 510(k) number K955102.

Who is the listed applicant for BIODATA TESTOSTERONE MAIA KIT?

The FDA 510(k) record lists Biochem Immunosystems (U.S.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIODATA TESTOSTERONE MAIA KIT?

The FDA product code for BIODATA TESTOSTERONE MAIA KIT is CDZ.

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Other records listing Biochem Immunosystems (U.S.), 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.

K971761PERSONALLAB AUTOMATED MICROPLATE ANALYZERK960072SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AXK954065BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT

Related Devices (Code: CDZ)

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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.

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