FDA 510(k)

MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL

K-Number: K011662 · 2001-07-30

Decision Date2001-07-30

Product CodeDDG

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 2001-07-30 under 510(k) number K011662. The device is classified under product code DDG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL?

MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL is a medical device that received FDA 510(k) clearance on 2001-07-30. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K011662.

When did MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL receive FDA 510(k) clearance?

MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL received FDA 510(k) clearance on 2001-07-30, under 510(k) number K011662.

Who is the listed applicant for MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL?

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

What is the FDA product code for MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL?

The FDA product code for MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL is DDG.

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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.