Tissue-Tek Immunohistology Kit Lysozzm
FDA 510(k) K842470 · Miles Laboratories, Inc.
510(k) numberK842470
Submission
- Device name
- Tissue-Tek Immunohistology Kit Lysozzm
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- June 25, 1984
- Decision date
- August 28, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFH – Kappa, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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Questions and answers
When was Tissue-Tek Immunohistology Kit Lysozzm cleared by the FDA?
Tissue-Tek Immunohistology Kit Lysozzm (K842470) received a 510(k) decision of Substantially Equivalent on August 28, 1984, 64 days after the submission was received.
What is the product code of K842470?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.