Pneumocystis Carinii Histology Control Slides
FDA 510(k) K881108 · Sigma Diagnostics, Inc.
510(k) numberK881108
Submission
- Device name
- Pneumocystis Carinii Histology Control Slides
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- March 15, 1988
- Decision date
- April 12, 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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| K943228 | Microsporidium Control SetLJG · Traditional | Meridian Diagnostics, Inc. | 10/27/1994SE |
| K924893 | Microsporidium Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 01/15/1993SE |
| K890718 | Gram Stain Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 03/16/1989SE |
| K890670 | Cryptosporidium Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 03/16/1989SE |
| K890616 | Bion Direct Identification Control SlideLJG · Traditional | Bion Ent., Ltd. | 02/17/1989SE |
| 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 Pneumocystis Carinii Histology Control Slides cleared by the FDA?
Pneumocystis Carinii Histology Control Slides (K881108) received a 510(k) decision of Substantially Equivalent on April 12, 1988, 28 days after the submission was received.
What is the product code of K881108?
The FDA product code is LJG – Quality Control Slides, a Class I (low risk) device regulated under 21 CFR 866.2660.