Pharmacia Specific Ige Control
FDA 510(k) K911631 · Pharmacia, Inc.
510(k) numberK911631
Submission
- Device name
- Pharmacia Specific Ige Control
- Applicant
- Pharmacia, Inc.
New Brunswick, NJ, US - Received
- April 11, 1991
- Decision date
- April 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| 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 Pharmacia Specific Ige Control cleared by the FDA?
Pharmacia Specific Ige Control (K911631) received a 510(k) decision of Substantially Equivalent on April 24, 1991, 13 days after the submission was received.
What is the product code of K911631?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.