Cardiozyme Ck-Total Reagents
FDA 510(k) K770972 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK770972
Submission
- Device name
- Cardiozyme Ck-Total Reagents
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- May 31, 1977
- Decision date
- July 15, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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Questions and answers
When was Cardiozyme Ck-Total Reagents cleared by the FDA?
Cardiozyme Ck-Total Reagents (K770972) received a 510(k) decision of Substantially Equivalent on July 15, 1977, 45 days after the submission was received.