Till-U-Test G.C. Gonococus Slide
FDA 510(k) K831268 · Pasco Laboratories, Inc.
510(k) numberK831268
Submission
- Device name
- Till-U-Test G.C. Gonococus Slide
- Applicant
- Pasco Laboratories, Inc.
Mchenry, IL, US - Received
- April 18, 1983
- Decision date
- May 13, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTY – Culture Media, For Isolation Of Pathogenic Neisseria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2410
- Specialty
- Microbiology
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| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | Bioclinical Systems, Inc. | 02/03/1994SE |
| K934331 | Thayer Martin, Modified Pill PocketJTY · Traditional | Hardy Diagnostics | 12/21/1993SE |
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| K881552 | Proteose No. 3 AgarJTY · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
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Questions and answers
When was Till-U-Test G.C. Gonococus Slide cleared by the FDA?
Till-U-Test G.C. Gonococus Slide (K831268) received a 510(k) decision of Substantially Equivalent on May 13, 1983, 25 days after the submission was received.
What is the product code of K831268?
The FDA product code is JTY – Culture Media, For Isolation Of Pathogenic Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.2410.