Ria System for Human Fe-Ritin
FDA 510(k) K781527 · Calbiochem-Behring Corp.
510(k) numberK781527
Submission
- Device name
- Ria System for Human Fe-Ritin
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- September 5, 1978
- Decision date
- October 3, 1978
- 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
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| 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 |
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| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
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Questions and answers
When was Ria System for Human Fe-Ritin cleared by the FDA?
Ria System for Human Fe-Ritin (K781527) received a 510(k) decision of Substantially Equivalent on October 3, 1978, 28 days after the submission was received.
What is the product code of K781527?
The FDA product code is JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin, a Class II (moderate risk) device regulated under 21 CFR 866.5340.