Anairobe-Tek
FDA 510(k) K802626 · Flow Laboratories, Inc.
510(k) numberK802626
Submission
- Device name
- Anairobe-Tek
- Applicant
- Flow Laboratories, Inc.
Mchenry, IL, US - Received
- October 23, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSP – Kit, Anaerobic Identification
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945489 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K945488 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K945487 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K944528 | Bblcrystal Anaerobe Id SystemJSP · Traditional | Becton Dickinson Microbiology Systems | 03/07/1995SE |
| K910666 | Vitek Anaerobe Identification Card, ModificationJSP · Traditional | Vitek Systems, Inc. | 04/03/1991SE |
| K900996 | Vitek Anaerobe Identification CardJSP · Traditional | Vitek Systems, Inc. | 05/11/1990SE |
| K881380 | B. FragtexJSP · Traditional | American Biomedical Products, Inc. | 10/06/1988SE |
| K882960 | Ids Rapid Ana SystemJSP · Traditional | Innovative Diagnostic Systems, Inc. | 08/12/1988SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | Oxoid U.S.A., Inc. | 11/04/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | American Micro Scan | 08/27/1986SE |
More from American Micro Scan
| 510(k) | Device | Decision |
|---|---|---|
| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
| K862066 | Titertek Microplate Washer S-12JTC · Traditional | 06/05/1986SE |
| 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 Anairobe-Tek cleared by the FDA?
Anairobe-Tek (K802626) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 20 days after the submission was received.
What is the product code of K802626?
The FDA product code is JSP – Kit, Anaerobic Identification, a Class I (low risk) device regulated under 21 CFR 866.2660.