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FDA 510(k)

COBAS-FP REAGENTS AND CALIBRATORS

K-Number: K941712 · 1994-06-13

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1994-06-13
Product CodeLGJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS-FP REAGENTS AND CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1994-06-13 under 510(k) number K941712. The device is classified under product code LGJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS-FP REAGENTS AND CALIBRATORS?

COBAS-FP REAGENTS AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K941712.

When did COBAS-FP REAGENTS AND CALIBRATORS receive FDA 510(k) clearance?

COBAS-FP REAGENTS AND CALIBRATORS received FDA 510(k) clearance on 1994-06-13, under 510(k) number K941712.

Who is the listed applicant for COBAS-FP REAGENTS AND CALIBRATORS?

The FDA 510(k) record lists Roche Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS-FP REAGENTS AND CALIBRATORS?

The FDA product code for COBAS-FP REAGENTS AND CALIBRATORS is LGJ.

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Related Devices (Code: LGJ)

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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.

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