HPL Ria Kit
FDA 510(k) K863188 · Biotecx Laboratories, Inc.
510(k) numberK863188
Submission
- Device name
- HPL Ria Kit
- Applicant
- Biotecx Laboratories, Inc.
Friendswood, TX, US - Received
- August 19, 1986
- Decision date
- September 25, 1986
- 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 |
|---|---|---|---|
| K780847 | Ninhydrin Reagent KitJMX · Traditional | Beckman Instruments, Inc. | 06/13/1978SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982298 | Opticoat T4 Eia KitKLI · Traditional | 02/03/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | 12/22/1998SE |
| K895407 | Cortisol Clasp-Bead Eia KitCGR · Traditional | 10/19/1989SE |
| K893620 | T3 Clasp-Bead Eia KitCDP · Traditional | 08/11/1989SE |
| K892853 | T4 Clasp-Bead Eia KitKLI · Traditional | 05/22/1989SE |
| K883765 | TBG 125I Ria Kit, Radioimmuno. of Serum ThyroxineKHQ · Traditional | 10/31/1988SE |
| K871211 | Progesterone Clasp Radioimmunoassay KitJLS · Traditional | 04/13/1987SE |
| K854876 | Aldosterone Direct Ria KitKQN · Traditional | 03/17/1986SE |
| K851540 | Estradiol Direct Ria KitCHP · Traditional | 06/06/1985SE |
| K844767 | Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional | 02/01/1985SE |
Questions and answers
When was HPL Ria Kit cleared by the FDA?
HPL Ria Kit (K863188) received a 510(k) decision of Substantially Equivalent on September 25, 1986, 37 days after the submission was received.
What is the product code of K863188?
The FDA product code is JMX – Ninhydrin, Nitrogen (Amino-Nitrogen), a Class I (low risk) device regulated under 21 CFR 862.1515.