CK-MB/LD-1 Control System
FDA 510(k) K894207 · Boehringer Mannheim Corp.
510(k) numberK894207
Submission
- Device name
- CK-MB/LD-1 Control System
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- June 19, 1989
- Decision date
- August 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was CK-MB/LD-1 Control System cleared by the FDA?
CK-MB/LD-1 Control System (K894207) received a 510(k) decision of Substantially Equivalent on August 28, 1989, 70 days after the submission was received.
What is the product code of K894207?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.