Insulin Autopak
FDA 510(k) K781086 · Micromedic Systems
510(k) numberK781086
Submission
- Device name
- Insulin Autopak
- Applicant
- Micromedic Systems
Mchenry, IL, US - Received
- June 29, 1978
- Decision date
- August 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K963911 | Alpco/Mercodia Insulin ElisaCFP · Traditional | American Laboratory Products Co., Ltd. | 11/01/1996SE |
| 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 |
More from Sorin Biomedica, Fiat, USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923643 | MedicoolILO · Traditional | 03/31/1993SE |
| K872309 | Micromedic Combostat Lh/Fsh KitCGJ · Traditional | 07/31/1987SE |
| K871505 | Autopak Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K871008 | Micromedic Neonatal T4 KitCDX · Traditional | 05/26/1987SE |
| K870904 | Micromedic Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K870245 | Autopak TSH Monoclonal Irma KitJLW · Traditional | 04/01/1987SE |
| K862206 | Taurus (TM) Automatic Liquid Scintillation CounterJJJ · Traditional | 08/04/1986SE |
| K860813 | Micromedic HTSH Monoclonal Irma KitJLW · Traditional | 07/14/1986SE |
| K861262 | MMS T3 UptakeKHQ · Traditional | 05/23/1986SE |
| K861320 | MMS T4 Ria KitCDX · Traditional | 04/24/1986SE |
Questions and answers
When was Insulin Autopak cleared by the FDA?
Insulin Autopak (K781086) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 46 days after the submission was received.
What is the product code of K781086?
The FDA product code is CFP – Radioimmunoassay, Immunoreactive Insulin, a Class I (low risk) device regulated under 21 CFR 862.1405.