Clinical Assays Gammacoat [125I] Ferritin Immuno.
FDA 510(k) K881138 · Baxter Healthcare Corp
510(k) numberK881138
Submission
- Device name
- Clinical Assays Gammacoat [125I] Ferritin Immuno.
- Applicant
- Baxter Healthcare Corp
Cambridge, MA, US - Received
- March 16, 1988
- Decision date
- April 21, 1988
- 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 |
|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | 12/16/2025SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | 07/28/2025SE |
| K243529 | Solution Administration SetsFPA · Traditional | 03/14/2025SE |
| K242339 | Intravascular Extension Sets and AccessoriesFPA · Traditional | 02/28/2025SE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | 09/05/2024SE |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional | 08/02/2024SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | 03/29/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | 03/29/2024SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | 03/12/2024SE |
Questions and answers
When was Clinical Assays Gammacoat [125I] Ferritin Immuno. cleared by the FDA?
Clinical Assays Gammacoat [125I] Ferritin Immuno. (K881138) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 36 days after the submission was received.
What is the product code of K881138?
The FDA product code is JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin, a Class II (moderate risk) device regulated under 21 CFR 866.5340.