Spirochetes Histology Control Slides
FDA 510(k) K881109 · Sigma Diagnostics, Inc.
510(k) numberK881109
Submission
- Device name
- Spirochetes Histology Control Slides
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- March 15, 1988
- Decision date
- April 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJG – Quality Control Slides
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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| K883571 | Histo-Check Parasitic Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883570 | Histo-Check Fungal Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883569 | Histo-Check Gram Negative SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883568 | Histo-Check Acid Fast SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883567 | Histo-Check Legionella Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
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Questions and answers
When was Spirochetes Histology Control Slides cleared by the FDA?
Spirochetes Histology Control Slides (K881109) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 37 days after the submission was received.
What is the product code of K881109?
The FDA product code is LJG – Quality Control Slides, a Class I (low risk) device regulated under 21 CFR 866.2660.