Alpco/Mercodia Insulin Elisa
FDA 510(k) K963911 · American Laboratory Products Co., Ltd.
510(k) numberK963911
Submission
- Device name
- Alpco/Mercodia Insulin Elisa
- Applicant
- American Laboratory Products Co., Ltd.
Windham, NH, US - Received
- September 30, 1996
- Decision date
- November 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFP – Radioimmunoassay, Immunoreactive Insulin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1405
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953084 | Access Ultrasensitive Insulin AssayCFP · Traditional | Bio-Rad Laboratories, Inc. | 09/25/1995SE |
| K920109 | Imx InsulinCFP · Traditional | Abbott Laboratories | 05/07/1992SE |
| K914820 | DSL Insulin Ria (DSL 1600)CFP · Traditional | Diagnostic Systems Laboratories, Inc. | 01/09/1992SE |
| K903628 | Aia-Pack IriCFP · Traditional | Tosoh Corp. | 09/07/1990SE |
| K901135 | Enzymun Test(R) InsulinCFP · Traditional | Boehringer Mannheim Corp. | 04/03/1990SE |
| K896572 | Rep(Tm) Spe PLUS-30 ProceduresCFP · Traditional | Helena Laboratories | 01/11/1990SE |
| K890837 | Ria-Gnost InsulinCFP · Traditional | Cambridge Medical Technology | 04/26/1989SE |
| K851071 | Pharmacia Insulin RiaCFP · Traditional | Pharmacia, Inc. | 04/12/1985SE |
| K841573 | Insulin Radioimmunoassay KitCFP · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/16/1984SE |
| K823939 | Wako Insulin TestCFP · Traditional | Wako Chemicals USA, Inc. | 01/28/1983SE |
More from Wako Chemicals USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012576 | CIC-C1Q EiaDAK · Traditional | 01/29/2002SE |
| K011415 | Alpco Milenia Anti-Tg EiaJZO · Traditional | 05/30/2001SE |
| K011201 | Alpco Milenia Anti-Tpo ElisaJZO · Traditional | 05/24/2001SE |
| K974702 | Orgentec ANTI-PR3 (C-Anca) ElisaMOB · Traditional | 02/17/1998SE |
| K974701 | Orgentec Anti-Mpo (P-Anca) ElisaMOB · Traditional | 02/17/1998SE |
| K972190 | Thyroglobulin Assay SystemJZO · Traditional | 07/14/1997SE |
| K970932 | Orgentec Micro-Albumin Eia AssayJIR · Traditional | 04/08/1997SE |
| K962062 | Orgentec Anti-Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962057 | Orgentec Anti-Rnp/Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962055 | Orgentec Anti-Scl 70 ElisaLJM · Traditional | 11/15/1996SE |
Questions and answers
When was Alpco/Mercodia Insulin Elisa cleared by the FDA?
Alpco/Mercodia Insulin Elisa (K963911) received a 510(k) decision of Substantially Equivalent on November 1, 1996, 32 days after the submission was received.
What is the product code of K963911?
The FDA product code is CFP – Radioimmunoassay, Immunoreactive Insulin, a Class I (low risk) device regulated under 21 CFR 862.1405.