Rosco Pyrr
FDA 510(k) K894221 · Pro-Lab, Inc.
510(k) numberK894221
Submission
- Device name
- Rosco Pyrr
- Applicant
- Pro-Lab, Inc.
Round Rock, TX, US - Received
- June 19, 1989
- Decision date
- September 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JTO
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|---|---|---|---|
| K050352 | In-Vitro Diagnostic Vaginitis Test KitJTO · Traditional | Ameritek Research, LLC | 09/01/2005SE |
| K970832 | Pyr SwabJTO · Traditional | Remel, Inc. | 04/24/1997SE |
| K970834 | Gram SwabJTO · Traditional | Remel, Inc. | 04/17/1997SE |
| K970833 | Indole SwabJTO · Traditional | Remel, Inc. | 04/02/1997SE |
| K970009 | Lyfo(Tm) Differential Disk-BacitracinJTO · Traditional | Microbiologics, Inc. | 02/06/1997SE |
| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | Innovative Diagnostic Systems, Inc. | 10/08/1996SE |
| K961191 | ColiscreenJTO · Traditional | Hardy Diagnostics | 06/17/1996SE |
| K960996 | M. Cat Butyrate DiskJTO · Traditional | Hardy Diagnostics | 04/18/1996SE |
| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | Difco Laboratories, Inc. | 02/06/1996SE |
More from Difco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934383 | Prolex (Streptoccal Grouping Latex Kit)GTZ · Traditional | 01/27/1995SE |
| K914419 | Amniotest(Tm)HIO · Traditional | 09/01/1993SE |
| K921421 | Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional | 07/28/1992SE |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | 01/24/1991SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | 03/20/1987SE |
| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
| K861889 | D'Ala Rapid TestJTO · Traditional | 06/03/1986SE |
Questions and answers
When was Rosco Pyrr cleared by the FDA?
Rosco Pyrr (K894221) received a 510(k) decision of Substantially Equivalent on September 28, 1989, 101 days after the submission was received.
What is the product code of K894221?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.