Gram Swab
FDA 510(k) K970834 · Remel, Inc.
510(k) numberK970834
Submission
- Device name
- Gram Swab
- Applicant
- Remel, Inc.
Lenexa, KS, US - Received
- March 7, 1997
- Decision date
- April 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | Difco Laboratories, Inc. | 02/06/1996SE |
| K954812 | Lyfo(Tm) Differiental Disk-PyrJTO · Traditional | Microbiologics, Inc. | 12/20/1995SE |
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Questions and answers
When was Gram Swab cleared by the FDA?
Gram Swab (K970834) received a 510(k) decision of Substantially Equivalent on April 17, 1997, 41 days after the submission was received.
What is the product code of K970834?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.