Microsporidium Control Set
FDA 510(k) K943228 · Meridian Diagnostics, Inc.
510(k) numberK943228
Submission
- Device name
- Microsporidium Control Set
- Applicant
- Meridian Diagnostics, Inc.
Cincinnati, OH, US - Received
- July 6, 1994
- Decision date
- October 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
| K883208 | Histo-Check SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 08/25/1988SE |
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Questions and answers
When was Microsporidium Control Set cleared by the FDA?
Microsporidium Control Set (K943228) received a 510(k) decision of Substantially Equivalent on October 27, 1994, 113 days after the submission was received.
What is the product code of K943228?
The FDA product code is LJG – Quality Control Slides, a Class I (low risk) device regulated under 21 CFR 866.2660.