Beckman Liquid-Stat Ld-L-Uv Enzyme
FDA 510(k) K802572 · Beckman Instruments, Inc.
510(k) numberK802572
Submission
- Device name
- Beckman Liquid-Stat Ld-L-Uv Enzyme
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- October 17, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1440
- Specialty
- Clinical Chemistry
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| K970684 | Lactate Dehydrogenase (LD)CFJ · Traditional | Randox Laboratories, Ltd. | 05/07/1997SE |
| K971398 | Ld-L ReagentCFJ · Traditional | Carolina Liquid Chemistries Corp. | 05/02/1997SE |
| K964912 | Lactate DehydrogenaseCFJ · Traditional | Derma Media Lab., Inc. | 01/09/1997SE |
| K961431 | Lactate Dehydrogenase Reagent SetCFJ · Traditional | Pointe Scientific, Inc., | 06/03/1996SE |
| K952747 | Lactate Dehydrogenase Reagent SystemCFJ · Traditional | Medical Diagnostic Technologies, Inc. | 08/07/1995SE |
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Questions and answers
When was Beckman Liquid-Stat Ld-L-Uv Enzyme cleared by the FDA?
Beckman Liquid-Stat Ld-L-Uv Enzyme (K802572) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 26 days after the submission was received.
What is the product code of K802572?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.