Slide, Lab-Tek Covered Micro
FDA 510(k) K760278 · Miles Laboratories, Inc.
510(k) numberK760278
Submission
- Device name
- Slide, Lab-Tek Covered Micro
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- July 23, 1976
- Decision date
- August 30, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891604 | The Cen-Slide(Tm) Centrifuge TubeKEW · Traditional | Davstar California, Inc. | 06/16/1989SE |
| K890042 | Microscope Slides PrecoatedKEW · Traditional | Stat Path | 01/13/1989SE |
| K882357 | Microscope Slides Precoated W/Histogrip & Poly-LyKEW · Traditional | Stat Path | 06/16/1988SE |
| K831065 | Sectioning Aid KitKEW · Traditional | Technicon Instruments Corp. | 06/08/1983SE |
| K820100 | Frosted Glass SlidesKEW · Traditional | Stan-Pak Ent. | 03/04/1982SE |
| K813242 | Quantimetric 2 Test KitKEW · Traditional | Kallestad Laboratories, Inc. | 12/02/1981SE |
| K800232 | Abco Ultra Slide Microscope SlideKEW · Traditional | Abco Dealers, Inc. | 02/21/1980SE |
More from Abco Dealers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Slide, Lab-Tek Covered Micro cleared by the FDA?
Slide, Lab-Tek Covered Micro (K760278) received a 510(k) decision of Substantially Equivalent on August 30, 1976, 38 days after the submission was received.
What is the product code of K760278?
The FDA product code is KEW – Slides, Microscope, a Class I (low risk) device regulated under 21 CFR 864.3010.