Multichem Ldh-L Reagent
FDA 510(k) K872010 · Simmler, Inc.
510(k) numberK872010
Submission
- Device name
- Multichem Ldh-L Reagent
- Applicant
- Simmler, Inc.
St. Louis, MO, US - Received
- May 26, 1987
- Decision date
- June 11, 1987
- 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
Other 510(k)s with product code CFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131975 | Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace Ldh-L…CFJ · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 10/02/2013SE |
| K091544 | S-Test Lactate Dehydrogenase (LD), Model RC 0017CFJ · Traditional | Alfa Wassermann, Inc. | 09/09/2009SE |
| K051108 | Piccolo Lactate Dephydrogenase Test SystemCFJ · Traditional | Abaxis, Inc. | 07/08/2005SE |
| K974859 | Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30CFJ · Traditional | Diagnostic Chemicals , Ltd. | 01/22/1998SE |
| K973589 | Liquid Ldh-L Reagent SetCFJ · Traditional | Pointe Scientific, Inc., | 10/08/1997SE |
| 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 |
More from Medical Diagnostic Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895745 | Sickle Cell Solubility Test KitJBB · Traditional | 11/29/1989SE |
| K874903 | Multichem(R) Y -Glutamyltransferase (Y -Gt)JPZ · Traditional | 02/11/1988SE |
| K874595 | Multichem (R) Magnesium ReagentJGJ · Traditional | 01/21/1988SE |
| K874820 | Multichem HDL Precipitating Reagent #S0914LBR · Traditional | 01/07/1988SE |
| K874812 | Multichem Chloride Reagent S0933CHJ · Traditional | 12/18/1987SE |
| K874311 | Multichem (R) Total BilirubinCIG · Traditional | 11/25/1987SE |
| K874049 | Multichem Albumin Reagent S0902CIX · Traditional | 10/29/1987SE |
| K874038 | Multichem Inorganic Phosphorous S0923CEO · Traditional | 10/28/1987SE |
| K873725 | Multichem Creatinine Reagent S0917CGX · Traditional | 10/20/1987SE |
| K873761 | Multichem Alkaline Phosphatase (S0903)CJE · Traditional | 10/07/1987SE |
Questions and answers
When was Multichem Ldh-L Reagent cleared by the FDA?
Multichem Ldh-L Reagent (K872010) received a 510(k) decision of Substantially Equivalent on June 11, 1987, 16 days after the submission was received.
What is the product code of K872010?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.