Alternate Procedure, Pharmacia Ige Eia
FDA 510(k) K882616 · Pharmacia, Inc.
510(k) numberK882616
Submission
- Device name
- Alternate Procedure, Pharmacia Ige Eia
- Applicant
- Pharmacia, Inc.
Piscataway, NJ, US - Received
- June 24, 1988
- Decision date
- August 4, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHR – Radioimmunoassay, Immunoglobulins (D, E)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code JHR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061970 | Elecsys Ige II ImmunoassayJHR · Special | Roche Diagnostics | 08/31/2006SE |
| K984326 | Elecys Ige AssayJHR · Traditional | Boehringer Mannheim Corp. | 02/08/1999SE |
| K960067 | Immilite Total IgeJHR · Traditional | Diagnostic Products Corp. | 02/14/1996SE |
| K931703 | Immulite Total IgeJHR · Traditional | Diagnostic Products Corp. | 08/16/1993SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | Ventrex Laboratories, Inc. | 07/31/1990SE |
| K901859 | Coat-A-Count Total Ige Irma, Catalog #IKIE1, IKIE2JHR · Traditional | Diagnostic Products Corp. | 05/03/1990SE |
| K873077 | Pharmacia Ige EiaJHR · Traditional | Pharmacia, Inc. | 10/20/1987SE |
| K840103 | Radioimmunoassay for Total Ige HumanJHR · Traditional | Techniclone Intl. | 02/10/1984SE |
More from Techniclone Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K974350 | Allergan Immuno Cap M4, M8, K70DHB · Traditional | 02/09/1998SE |
| K972364 | Unicap PhadiatopDHB · Traditional | 09/04/1997SE |
| K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82DHB · Traditional | 07/03/1997SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | 06/30/1997SE |
| K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHDGC · Traditional | 04/23/1997SE |
| K962274 | Unicap 100DHB · Traditional | 09/12/1996SE |
| K941993 | Pharmacia Cap System Phadiatop FeiaDHB · Traditional | 01/30/1996SE |
| K954337 | Genotropin MixerFMF · Traditional | 11/13/1995SE |
| K951025 | Piston SyringeFMF · Traditional | 10/19/1995SE |
| K952025 | RobocapJQW · Traditional | 07/26/1995SE |
Questions and answers
When was Alternate Procedure, Pharmacia Ige Eia cleared by the FDA?
Alternate Procedure, Pharmacia Ige Eia (K882616) received a 510(k) decision of Substantially Equivalent on August 4, 1988, 41 days after the submission was received.
What is the product code of K882616?
The FDA product code is JHR – Radioimmunoassay, Immunoglobulins (D, E), a Class II (moderate risk) device regulated under 21 CFR 866.5510.