Trypsin 1%
FDA 510(k) K771955 · Flow Laboratories, Inc.
510(k) numberK771955
Submission
- Device name
- Trypsin 1%
- Applicant
- Flow Laboratories, Inc.
Mchenry, IL, US - Received
- October 17, 1977
- Decision date
- November 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IBG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K802493 | SputasolIBG · Traditional | Oxoid U.S.A., Inc. | 11/12/1980SE |
More from Oxoid U.S.A., Inc.
| 510(k) | Device | Decision |
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| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
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| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | 05/20/1986SE |
| K860762 | Gamma-Free Horse SerumKIS · Traditional | 03/10/1986SE |
| K860752 | Goat Serum (29-391-54)KIS · Traditional | 03/10/1986SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | 03/25/1985SE |
| K844567 | Titertek Twinreader 78-630-00JJQ · Traditional | 03/21/1985SE |
| K844419 | Titertek Multiskan MSS/340JJQ · Traditional | 03/21/1985SE |
Questions and answers
When was Trypsin 1% cleared by the FDA?
Trypsin 1% (K771955) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 36 days after the submission was received.
What is the product code of K771955?
The FDA product code is IBG – Trypsin, a Class I (low risk) device regulated under 21 CFR 864.4400.