Amerlex-M CAMP(125)ASSAY System RPA.508 (100 Kit)
FDA 510(k) K860253 · Amersham Corp.
510(k) numberK860253
Submission
- Device name
- Amerlex-M CAMP(125)ASSAY System RPA.508 (100 Kit)
- Applicant
- Amersham Corp.
Arlington Heights, IL, US - Received
- January 24, 1986
- Decision date
- March 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHO – Radioimmunoassay, Cyclic Amp
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1230
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K844135 | Plasma Cyclic Adenosine Monophosphate by RadioimmuCHO · Traditional | Immuno Nuclear Corp. | 03/05/1985SE |
| K841478 | Rianen Cyclic-Amp RadioimmunoassayCHO · Traditional | New England Nuclear | 06/14/1984SE |
| K823504 | Cyclic Adenosine Monophoshate by RadioCHO · Traditional | Immuno Nuclear Corp. | 01/28/1983SE |
| K811746 | King Diagnostics Cholesterol-Fe TestCHO · Traditional | King Diagnostics, Inc. | 07/10/1981SE |
| K811273 | Cyclic Amp Radioimmunoassay Kit [125I]CHO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/27/1981SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K914135 | Amerlite(Tm) PROLACTIN-30 Assay, LAN.0086/2086CFT · Traditional | 02/18/1992SE |
| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | 07/22/1991SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | 07/17/1991SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | 11/02/1990SE |
| K902760 | Amersham TSH Control SeraJJX · Traditional | 07/27/1990SE |
| K901857 | GADOLINIUM-153 Bone Densitometer (GDC.10413)KGI · Traditional | 07/09/1990SE |
| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
Questions and answers
When was Amerlex-M CAMP(125)ASSAY System RPA.508 (100 Kit) cleared by the FDA?
Amerlex-M CAMP(125)ASSAY System RPA.508 (100 Kit) (K860253) received a 510(k) decision of Substantially Equivalent on March 14, 1986, 49 days after the submission was received.
What is the product code of K860253?
The FDA product code is CHO – Radioimmunoassay, Cyclic Amp, a Class II (moderate risk) device regulated under 21 CFR 862.1230.