Genotropin Mixer
FDA 510(k) K954337 · Pharmacia, Inc.
510(k) numberK954337
Submission
- Device name
- Genotropin Mixer
- Applicant
- Pharmacia, Inc.
Columbus, OH, US - Received
- September 18, 1995
- Decision date
- November 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
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| 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 |
| K951025 | Piston SyringeFMF · Traditional | 10/19/1995SE |
| K952025 | RobocapJQW · Traditional | 07/26/1995SE |
| K911903 | Allergans Pharmacia Cap Sys.Rast Ria/FeiaDHB · Traditional | 08/12/1991SE |
Questions and answers
When was Genotropin Mixer cleared by the FDA?
Genotropin Mixer (K954337) received a 510(k) decision of Substantially Equivalent on November 13, 1995, 56 days after the submission was received.
What is the product code of K954337?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.