Rep(Tm) LD-2 Stat Kit, Cat. No. 3078
FDA 510(k) K892818 · Helena Laboratories
510(k) numberK892818
Submission
- Device name
- Rep(Tm) LD-2 Stat Kit, Cat. No. 3078
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 17, 1989
- Decision date
- June 20, 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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| K894081 | Rocho Isomune - LDCFE · Traditional | Roche Diagnostic Systems, Inc. | 08/31/1989SE |
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Questions and answers
When was Rep(Tm) LD-2 Stat Kit, Cat. No. 3078 cleared by the FDA?
Rep(Tm) LD-2 Stat Kit, Cat. No. 3078 (K892818) received a 510(k) decision of Substantially Equivalent on June 20, 1989, 64 days after the submission was received.
What is the product code of K892818?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.