Adenovirus Group-Fa Labelled Preserum
FDA 510(k) K770811 · Flow Laboratories, Inc.
510(k) numberK770811
Submission
- Device name
- Adenovirus Group-Fa Labelled Preserum
- Applicant
- Flow Laboratories, Inc.
Mchenry, IL, US - Received
- May 3, 1977
- Decision date
- May 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNY – Antisera, Fluorescent, Adenovirus 1-33
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3020
- Specialty
- Microbiology
Other 510(k)s with product code GNY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922801 | Resp. Panel 1 Indirect Immunofluorescence AssayGNY · Traditional | Light Diagnostics | 01/06/1993SE |
| K885310 | Murine Monoclonal Anti-Adenovirus IggGNY · Traditional | Whittaker Bioproducts, Inc. | 02/16/1989SE |
| K770807 | Adenovirus-Group Fa Labelled (8-651 RF)GNY · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
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|---|---|---|
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| 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 Adenovirus Group-Fa Labelled Preserum cleared by the FDA?
Adenovirus Group-Fa Labelled Preserum (K770811) received a 510(k) decision of Substantially Equivalent on May 20, 1977, 17 days after the submission was received.
What is the product code of K770811?
The FDA product code is GNY – Antisera, Fluorescent, Adenovirus 1-33, a Class I (low risk) device regulated under 21 CFR 866.3020.