FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MIDAS 1000 WRIGHT GIEMSA STAIN #66020
K Number: K822981
·
Decision Oct 27, 1982
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
32
Applicant Total
62
Review Days
19
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Basic Information
- Device Name
- MIDAS 1000 WRIGHT GIEMSA STAIN #66020
- K Number
- K822981
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Emd Chemicals, Inc.
- Date Received
- October 8, 1982
- Decision Date
- October 27, 1982
- Product Code
- IAF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| IAF | Wright'S Stain | FDA class 1 | Hematology |
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| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Oct 1, 1997 | Substantially Equivalent |
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| K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 | Sep 6, 1995 | Substantially Equivalent |
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| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | May 15, 1995 | Substantially Equivalent |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | Dec 7, 1994 | Substantially Equivalent |
| K945368 | PHOSPHORUS TEST (PHOS) | Dec 2, 1994 | Substantially Equivalent |