FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LACTO-PHENOL ANILINE BLUE MOUNTING FLUID
K Number: K812192
·
Decision Aug 31, 1981
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
15
Applicant Total
28
Review Days
28
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Basic Information
- Device Name
- LACTO-PHENOL ANILINE BLUE MOUNTING FLUID
- K Number
- K812192
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- American Scientific Products
- Date Received
- August 3, 1981
- Decision Date
- August 31, 1981
- Product Code
- LED
- 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 |
|---|---|---|---|
| LED | Stains, Chemical Solution | FDA class 1 | Hematology |
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Other Clearances by American Scientific Products
| K Number | Device Name | ||
|---|---|---|---|
| K864824 | INFECTIOUS TISSUE KIT | Dec 24, 1986 | Substantially Equivalent |
| K844042 | BLOOD DILUTION VIAL | Oct 23, 1984 | Substantially Equivalent |
| K831634 | GLUCOSE REAGENT B6360-11 | Jul 19, 1983 | Substantially Equivalent |
| K831625 | UREA NITROGEN-BUN-REAGENTS B6360-12 | Jul 7, 1983 | Substantially Equivalent |
| K831626 | UREA NITROGEN-BUN-REAGENTS B6370-11A | Jul 7, 1983 | Substantially Equivalent |
| K831628 | CREATININE REAGENTS B6370-13 | Jul 6, 1983 | Substantially Equivalent |
| K831624 | GLUCOSE REAGENT KITS-B6370-10A | Jul 6, 1983 | Substantially Equivalent |
| K831627 | CREATININE REAGENTS B6360-10 | Jul 6, 1983 | Substantially Equivalent |
| K831569 | REAGENT CUPS | Jun 30, 1983 | Substantially Equivalent |
| K831571 | ROTOR | Jun 30, 1983 | Substantially Equivalent |