Rapid Glutamic Acid Decarboxylase (GDC) Microtube
FDA 510(k) K860301 · Carr-Scarborough Microbiologicals, Inc.
510(k) numberK860301
Submission
- Device name
- Rapid Glutamic Acid Decarboxylase (GDC) Microtube
- Applicant
- Carr-Scarborough Microbiologicals, Inc.
Stone Mountain, GA, US - Received
- January 28, 1986
- Decision date
- February 6, 1986
- 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
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| K863216 | Neis NzyJTO · Traditional | 09/15/1986SE |
| K860302 | Pyr DiscsJTO · Traditional | 02/05/1986SE |
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Questions and answers
When was Rapid Glutamic Acid Decarboxylase (GDC) Microtube cleared by the FDA?
Rapid Glutamic Acid Decarboxylase (GDC) Microtube (K860301) received a 510(k) decision of Substantially Equivalent on February 6, 1986, 9 days after the submission was received.
What is the product code of K860301?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.