Histological Embedding Media
FDA 510(k) K803241 · Miles Laboratories, Inc.
510(k) numberK803241
Submission
- Device name
- Histological Embedding Media
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- December 23, 1980
- Decision date
- January 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893772 | Tissue Embedding MediumKEO · Traditional | Stephens Scientific | 06/22/1989SE |
| K862223 | Micro Thin* ParaffinKEO · Traditional | Richard-Allan Medical Ind., Inc. | 06/17/1986SE |
| K862141 | Histology ParaffinKEO · Traditional | Erie Scientific Co. | 06/13/1986SE |
| K861270 | Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional | Surgipath Medical Industries, Inc. | 04/11/1986SE |
| K842053 | Paraplast Extra Tissue Embedding Med.KEO · Traditional | Sherwood Medical Co. | 06/26/1984SE |
| K833071 | Technicon ParacutKEO · Traditional | Technicon Instruments Corp. | 10/14/1983SE |
| K831580 | Paraffin Infiltration MediumKEO · Traditional | Surgipath Medical Industries, Inc. | 06/17/1983SE |
| K812191 | Vaspar SealentKEO · Traditional | American Scientific Products | 08/31/1981SE |
| K810568 | Paraffin Embedding MediumKEO · Traditional | Surgipath Medical Industries, Inc. | 03/17/1981SE |
| K760602 | Sorvall Embedding MediumKEO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/21/1976SE |
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| 510(k) | Device | Decision |
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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 Histological Embedding Media cleared by the FDA?
Histological Embedding Media (K803241) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 36 days after the submission was received.
What is the product code of K803241?
The FDA product code is KEO – Formulations, Paraffin, All, a Class I (low risk) device regulated under 21 CFR 864.4010.