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FDA 510(k)

STRATUS CS MYO CALPAK

K-Number: K981101 · 1998-04-15

ApplicantDade Behring, Inc.
Decision Date1998-04-15
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS CS MYO 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 1998-04-15 under 510(k) number K981101. 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 MYO CALPAK?

STRATUS CS MYO CALPAK is a medical device that received FDA 510(k) clearance on 1998-04-15. The listed applicant is Dade Behring, Inc.. The 510(k) number is K981101.

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

STRATUS CS MYO CALPAK received FDA 510(k) clearance on 1998-04-15, under 510(k) number K981101.

Who is the listed applicant for STRATUS CS MYO 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 MYO CALPAK?

The FDA product code for STRATUS CS MYO 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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