Normal Unassayed Control Sera
FDA 510(k) K780351 · Macomb Chemical Co.
510(k) numberK780351
Submission
- Device name
- Normal Unassayed Control Sera
- Applicant
- Macomb Chemical Co.
Mchenry, IL, US - Received
- March 3, 1978
- Decision date
- April 24, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K830095 | Rapid Chem Analyzer IIJJF · Traditional | 01/28/1983SE |
| K823720 | SpectrophotometerJJQ · Traditional | 01/07/1983SE |
| K810958 | GlycohemoglobinLCP · Traditional | 09/16/1981SE |
| K801086 | P-Nitrophenyl Phosphate · Traditional | 05/28/1980SE |
| K800719 | Enzymatic Urea Nitrogen Reagent Set ReviCDQ · Traditional | 05/08/1980SE |
| K800720 | Macomb Nad-Nicotinamide Adenine Dinucleo · Traditional | 04/21/1980SE |
| K792533 | Creatine Phosphokinase (CPK) Reagent SetJHW · Traditional | 01/11/1980SE |
| K792532 | Glucose (Hexokinase) Reagent SetCFR · Traditional | 01/11/1980SE |
| K791669 | Glucose Oxidase Reagent SetCGA · Traditional | 09/24/1979SE |
| K791511 | Enzymatic Reagent Set, 4X250 Ml.CHH · Traditional | 09/04/1979SE |
Questions and answers
When was Normal Unassayed Control Sera cleared by the FDA?
Normal Unassayed Control Sera (K780351) received a 510(k) decision of Substantially Equivalent on April 24, 1978, 52 days after the submission was received.
What is the product code of K780351?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.