FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HAYEM DILUTING FLUID
K Number: K842929
·
Decision Sep 7, 1984
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
37
Applicant Total
50
Review Days
44
Basic Information
- Device Name
- HAYEM DILUTING FLUID
- K Number
- K842929
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- E K IND., INC.
- Date Received
- July 25, 1984
- Decision Date
- September 7, 1984
- Product Code
- GIF
- 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 |
|---|---|---|---|
| GIF | Diluent, Blood Cell | FDA class 1 | Hematology |
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Other Clearances by E K IND., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K842931 | DRABKIN REAGENT | Sep 21, 1984 | Substantially Equivalent |
| K842938 | ACETIC ACID 1% V/V | Sep 14, 1984 | Substantially Equivalent |
| K842935 | ACETIC ACID, 5% V/V | Sep 12, 1984 | Substantially Equivalent |
| K842936 | ACETIC ACID, 3% V/V | Sep 12, 1984 | Substantially Equivalent |
| K842934 | DECOLORIZING FLUIC, ACID-ALCOHOL 3% | Sep 12, 1984 | Substantially Equivalent |
| K842937 | ACETIC ACID 2% V/V | Sep 12, 1984 | Substantially Equivalent |
| K842933 | CARBOL-FUCHSIN, ZIEHL-NEEDSEN | Sep 11, 1984 | Substantially Equivalent |
| K842925 | MUCI-CARMINE STAIN, MAYER'S FORMULA | Sep 11, 1984 | Substantially Equivalent |
| K842923 | PICRIC ACID 1% W/V | Sep 11, 1984 | Substantially Equivalent |
| K842919 | SCHIFF REAGENT FUCHSIN-SULFUROUS ACID | Sep 11, 1984 | Substantially Equivalent |