FDA 510(k)

FIBRINOGEN FDP CONTROL

K-Number: K915503 · 1992-01-30

Decision Date1992-01-30

Product CodeDAP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FIBRINOGEN FDP CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Cala Diagnostics. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K915503. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOGEN FDP CONTROL?

FIBRINOGEN FDP CONTROL is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Cala Diagnostics. The 510(k) number is K915503.

When did FIBRINOGEN FDP CONTROL receive FDA 510(k) clearance?

FIBRINOGEN FDP CONTROL received FDA 510(k) clearance on 1992-01-30, under 510(k) number K915503.

Who is the listed applicant for FIBRINOGEN FDP CONTROL?

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

What is the FDA product code for FIBRINOGEN FDP CONTROL?

The FDA product code for FIBRINOGEN FDP CONTROL is DAP.

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Other records listing Cala Diagnostics as applicant

K944247CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL K944246CARDIOCHEX CKMB MASS MEASUREMENT CONTROL K944243CARDIOCHEX K930874LD-1 CONTROL-LEVEL 1 & 2 K930875CKMB CONTROL - LEVEL 1,2,3 K930873CKMB ISOENZYME CONTROL-LEVEL 1,2.3

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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.