LDH Isoenzyme Control Serum
FDA 510(k) K780096 · Worthington Biochemical Corp.
510(k) numberK780096
Submission
- Device name
- LDH Isoenzyme Control Serum
- Applicant
- Worthington Biochemical Corp.
Mchenry, IL, US - Received
- January 18, 1978
- Decision date
- March 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K780389 | HDL Reagent Set for LipoproteinsCHH · Traditional | 04/19/1978SE |
| K772356 | LDH Isoenzyme Column Reagent SetCEX · Traditional | 01/24/1978SE |
| K772025 | Uric Acid Std. for Quant. Uric AcidJIS · Traditional | 11/11/1977SE |
| K771143 | Inorganic Phosphorus StandardsJIT · Traditional | 07/11/1977SE |
| K771001 | Statzyme GlucoseCGA · Traditional | 07/11/1977SE |
| K770831 | Statzyme Uric Acid ReagentCDO · Traditional | 07/11/1977SE |
| K770470 | Worthington BunCDW · Traditional | 06/02/1977SE |
| K770277 | Cholesterol StandardsJIT · Traditional | 03/01/1977SE |
| K761263 | Cholesterol Automated ReagentCHH · Traditional | 12/29/1976SE |
| K761262 | Triglycerides (Lipase) Reagent SetCDT · Traditional | 12/29/1976SE |
Questions and answers
When was LDH Isoenzyme Control Serum cleared by the FDA?
LDH Isoenzyme Control Serum (K780096) received a 510(k) decision of Substantially Equivalent on March 3, 1978, 44 days after the submission was received.
What is the product code of K780096?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.