Santest 1AP
FDA 510(k) K862087 · Scientific Sales Intl., Inc.
510(k) numberK862087
Submission
- Device name
- Santest 1AP
- Applicant
- Scientific Sales Intl., Inc.
Kalamazoo, MI, US - Received
- June 2, 1986
- Decision date
- December 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKL – Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5420
- Specialty
- Immunology
Other 510(k)s with product code LKL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993441 | K-Assay ALPHA-1 AGLKL · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K964299 | N-Assay Tia Multi V-NlLKL · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K964257 | Immage Immunochemistry System ALPHA-1-ACID Glycoprotein (Aag) ReagentLKL · Traditional | Beckman Instruments, Inc. | 03/24/1997SE |
| K922417 | Al-Acid Glycoprotein Rid KitLKL · Traditional | The Binding Site, Ltd. | 08/20/1992SE |
| K904175 | Raichem (TM) Spia (TM) - Acid Glycoprotein ReagentLKL · Traditional | Reagents Applications, Inc. | 11/13/1990SE |
| K884217 | Technicon DPA-1 Analyte Alpha 1 Acid GlycoproteinLKL · Traditional | Technicon Instruments Corp. | 11/04/1988SE |
| K873868 | ALPHA-1-ACID Glycoprotein (Orosomucoid)LKL · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K861336 | Iap Plate TestLKL · Traditional | Scientific Sales Intl., Inc. | 04/25/1986SE |
| K841734 | Tago Fiffu-Gen, OrosomucoidLKL · Traditional | Tago, Inc. | 06/01/1984SE |
| K831960 | Test for Human Alpha One Acid Glyco-LKL · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |
More from Kent Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | 08/25/1995SE |
| K940799 | FlexguideBSR · Traditional | 08/18/1994SE |
| K860996 | Sanassay Ic TestDAK · Traditional | 03/30/1987SE |
| K861336 | Iap Plate TestLKL · Traditional | 04/25/1986SE |
| K853285 | Mywasher 5LIB · Traditional | 10/04/1985SE |
| K853284 | Myreader 7JJQ · Traditional | 10/04/1985SE |
| K853380 | SPR 2 AutodiluterJTC · Traditional | 09/12/1985SE |
| K853379 | Plate IncubatorJTQ · Traditional | 09/03/1985SE |
| K833022 | Air Uterine Displacer-Aud 120CCX · Traditional | 10/14/1983SE |
| K802416 | Salem/Resce Intubation GuideBSR · Traditional | 10/23/1980SE |
Questions and answers
When was Santest 1AP cleared by the FDA?
Santest 1AP (K862087) received a 510(k) decision of Substantially Equivalent on December 3, 1986, 184 days after the submission was received.
What is the product code of K862087?
The FDA product code is LKL – Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5420.