FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
K Number: K843427
·
Decision Oct 2, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
14
Applicant Total
20
Review Days
28
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Basic Information
- Device Name
- GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
- K Number
- K843427
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Accra Laboratories, Inc.
- Date Received
- September 4, 1984
- Decision Date
- October 2, 1984
- Product Code
- HZJ
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| HZJ | Stain, Papanicolau | FDA class 1 | Hematology |
Similar 510(k) Clearances
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Other Clearances by Accra Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K851493 | KINYOUN ACID FAST STAIN KIT | Apr 29, 1985 | Substantially Equivalent |
| K851494 | TWO-STEP ACID FAST BACTERIA STAIN | Apr 29, 1985 | Substantially Equivalent |
| K843425 | HARRIS HEMATOXYLIN, MERCURY FREE, ACID | Oct 2, 1984 | Substantially Equivalent |
| K843428 | BIOFIX | Sep 27, 1984 | Substantially Equivalent |
| K843426 | EOSIN Y 1% ALCOHOLIC | Sep 27, 1984 | Substantially Equivalent |
| K843429 | GRAM STAIN SET W/STABILIZED IODINE | Sep 14, 1984 | Substantially Equivalent |
| K831090 | HEMATOXYLIN GILL FORMULATION IX#56016 | Jun 8, 1983 | Substantially Equivalent |
| K830542 | HEMAQUIK II STAINING SOLUTION #55961 | Mar 17, 1983 | Substantially Equivalent |
| K823329 | PAPINCOLABU STAIN EA-36/50/65 & OG-6 | Dec 28, 1982 | Substantially Equivalent |
| K823328 | HARRIS HEMATOXYLIN | Dec 28, 1982 | Substantially Equivalent |