Ninhydrin Reagent Kit
FDA 510(k) K780847 · Beckman Instruments, Inc.
510(k) numberK780847
Submission
- Device name
- Ninhydrin Reagent Kit
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- May 23, 1978
- Decision date
- June 13, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMX – Ninhydrin, Nitrogen (Amino-Nitrogen)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1515
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K863188 | HPL Ria KitJMX · Traditional | Biotecx Laboratories, Inc. | 09/25/1986SE |
More from Biotecx Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Ninhydrin Reagent Kit cleared by the FDA?
Ninhydrin Reagent Kit (K780847) received a 510(k) decision of Substantially Equivalent on June 13, 1978, 21 days after the submission was received.
What is the product code of K780847?
The FDA product code is JMX – Ninhydrin, Nitrogen (Amino-Nitrogen), a Class I (low risk) device regulated under 21 CFR 862.1515.