Tissue-Tek III Microject Disp. Blade Sys
FDA 510(k) K801426 · Miles Laboratories, Inc.
510(k) numberK801426
Submission
- Device name
- Tissue-Tek III Microject Disp. Blade Sys
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- June 17, 1980
- Decision date
- July 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IDL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K863616 | Knife MakerIDL · Traditional | Surgipath Medical Industries, Inc. | 09/25/1986SE |
| K831921 | Disposable Microtome BladesIDL · Traditional | Polymer Technology Corp. | 07/29/1983SE |
| K831308 | Disposable Microtome BladeIDL · Traditional | Surgipath Medical Industries, Inc. | 05/16/1983SE |
| K813430 | Tissue Processing Cassettes & AccessIDL · Traditional | American Optical Corp. | 12/29/1981SE |
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| 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 Tissue-Tek III Microject Disp. Blade Sys cleared by the FDA?
Tissue-Tek III Microject Disp. Blade Sys (K801426) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 41 days after the submission was received.
What is the product code of K801426?
The FDA product code is IDL – Microtome, Accessories, a Class I (low risk) device regulated under 21 CFR 864.3010.