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FDA 510(k)

QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)

K-Number: K852418 · 1985-07-15

ApplicantAmf Biological and Diagnostics Co.
Decision Date1985-07-15
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) is the device name listed in this FDA 510(k) record. The listed applicant is Amf Biological and Diagnostics Co.. It received FDA 510(k) clearance on 1985-07-15 under 510(k) number K852418. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)?

QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Amf Biological and Diagnostics Co.. The 510(k) number is K852418.

When did QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) receive FDA 510(k) clearance?

QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) received FDA 510(k) clearance on 1985-07-15, under 510(k) number K852418.

Who is the listed applicant for QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)?

The FDA 510(k) record lists Amf Biological and Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)?

The FDA product code for QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) is JJY.

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Other records listing Amf Biological and Diagnostics Co. as applicant

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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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