Rocho Isomune - LD
FDA 510(k) K894081 · Roche Diagnostic Systems, Inc.
510(k) numberK894081
Submission
- Device name
- Rocho Isomune - LD
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- June 8, 1989
- Decision date
- August 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1445
- Specialty
- Clinical Chemistry
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Questions and answers
When was Rocho Isomune - LD cleared by the FDA?
Rocho Isomune - LD (K894081) received a 510(k) decision of Substantially Equivalent on August 31, 1989, 84 days after the submission was received.
What is the product code of K894081?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.