Irma Test, Nordiclab Ferritin
FDA 510(k) K782157 · Nordiclab Intl.
510(k) numberK782157
Submission
- Device name
- Irma Test, Nordiclab Ferritin
- Applicant
- Nordiclab Intl.
Mchenry, IL, US - Received
- December 22, 1978
- Decision date
- January 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
Other 510(k)s with product code JMG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234052 | Access FerritinJMG · Traditional | Beckman Coulter, Inc. | 03/20/2024SE |
| K052082 | Ferritin on the Access Immunoassay Systems, Model 33020JMG · Special | Beckman Coulter, Inc. | 08/19/2005SE |
| K964282 | Tina-Quant Ferritin AssayJMG · Traditional | Boehringer Mannheim Corp. | 07/30/1997SE |
| K971833 | Elecsys FerritinJMG · Traditional | Boehringer Mannheim Corp. | 06/02/1997SE |
| K963498 | Ferr Flex Reagent CartridgeJMG · Traditional | Dade Chemistry Systems, Inc. | 01/24/1997SE |
| K950393 | Ace(Tm) Cedia(R) Ferritin AssayJMG · Traditional | Schiapparelli Biosystems, Inc. | 05/16/1995SE |
| K926221 | Access Ferritin AssayJMG · Traditional | Bio-Rad Laboratories, Inc. | 01/13/1993SE |
| K925848 | Immulite FerritinJMG · Traditional | Diagnostic Products Corp. | 01/13/1993SE |
| K920829 | Cobas Core Ferritin EiaJMG · Traditional | Roche Diagnostic Systems, Inc. | 06/19/1992SE |
| K920318 | Cedia Ferritin AssayJMG · Traditional | Microgenics Corp. | 06/04/1992SE |
More from Microgenics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K801988 | Nordiclab Prostatic Acid Phosphatase RiaJFH · Traditional | 09/26/1980SE |
| K801989 | Nordiclab Ferritin Irma TestDBF · Traditional | 09/16/1980SE |
| K800922 | Nordiclab Progesterone Ria TestJLS · Traditional | 05/14/1980SE |
| K800921 | Nordiclab Testosterone Ria TestCDZ · Traditional | 05/14/1980SE |
| K800920 | Nordiclab Estradiol Ria TestCHP · Traditional | 05/14/1980SE |
| K792189 | Nordiclab Total Estriol Ria TestCGI · Traditional | 11/13/1979SE |
| K782099 | Ria Test, Nordicalb HPLJMF · Traditional | 01/10/1979SE |
Questions and answers
When was Irma Test, Nordiclab Ferritin cleared by the FDA?
Irma Test, Nordiclab Ferritin (K782157) received a 510(k) decision of Substantially Equivalent on January 17, 1979, 26 days after the submission was received.
What is the product code of K782157?
The FDA product code is JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin, a Class II (moderate risk) device regulated under 21 CFR 866.5340.