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FDA 510(k)

STRATUS CS TROP CALPAK

K-Number: K981100 · 1998-04-16

ApplicantDade Behring, Inc.
Decision Date1998-04-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS CS TROP CALPAK is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 1998-04-16 under 510(k) number K981100. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS CS TROP CALPAK?

STRATUS CS TROP CALPAK is a medical device that received FDA 510(k) clearance on 1998-04-16. The listed applicant is Dade Behring, Inc.. The 510(k) number is K981100.

When did STRATUS CS TROP CALPAK receive FDA 510(k) clearance?

STRATUS CS TROP CALPAK received FDA 510(k) clearance on 1998-04-16, under 510(k) number K981100.

Who is the listed applicant for STRATUS CS TROP CALPAK?

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

What is the FDA product code for STRATUS CS TROP CALPAK?

The FDA product code for STRATUS CS TROP CALPAK is JIT.

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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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