Titan Gel Rep LDH-30 HV
FDA 510(k) K874142 · Helena Laboratories
510(k) numberK874142
Submission
- Device name
- Titan Gel Rep LDH-30 HV
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- October 13, 1987
- Decision date
- November 24, 1987
- 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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| K921455 | Aca Lactate Dehydrogenase Isoenzyme 1 (LD1) MethodCFE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/29/1992SE |
| K905861 | Aca(R) Lactic Dehydrogenase Isoenzyme 1 (LD1) MethCFE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/06/1991SE |
| K894081 | Rocho Isomune - LDCFE · Traditional | Roche Diagnostic Systems, Inc. | 08/31/1989SE |
| K892818 | Rep(Tm) LD-2 Stat Kit, Cat. No. 3078CFE · Traditional | Helena Laboratories | 06/20/1989SE |
| K874145 | Titan Gel Rep LDH-6 HVCFE · Traditional | Helena Laboratories | 11/24/1987SE |
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Questions and answers
When was Titan Gel Rep LDH-30 HV cleared by the FDA?
Titan Gel Rep LDH-30 HV (K874142) received a 510(k) decision of Substantially Equivalent on November 24, 1987, 42 days after the submission was received.
What is the product code of K874142?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.