FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WAYMOUTH'S POWDER MEDIUM
K Number: K821917
·
Decision Jul 27, 1982
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
75
Review Days
29
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Basic Information
- Device Name
- WAYMOUTH'S POWDER MEDIUM
- K Number
- K821917
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Dutchland Laboratories, Inc.
- Date Received
- June 28, 1982
- Decision Date
- July 27, 1982
- Product Code
- KIT
- Advisory Committee
- Hematology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | FDA class 1 | Hematology |
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Other Clearances by Dutchland Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821913 | ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821912 | MCCOY'S POWDER MEDIUM 5A SUSPENSION | Jul 27, 1982 | Substantially Equivalent |
| K821918 | POWDERED RPMI-1603 MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821916 | IMPROVED MEM-RICHTER'S POWDER MODIF. | Jul 27, 1982 | Substantially Equivalent |
| K821919 | POWDERED RPMI-1634 MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821911 | S-MEM-JOKLIK'S POWDER | Jul 27, 1982 | Substantially Equivalent |
| K821914 | COON'S F-12 POWDER MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821915 | BME AUTOCLAVABLE MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K820926 | E-BME POWDERED MEDIUM | Apr 21, 1982 | Substantially Equivalent |
| K820919 | EARLE'S-199 POWDERED MEDIUM | Apr 21, 1982 | Substantially Equivalent |