FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAM STAIN
K Number: K843050
·
Decision Sep 11, 1984
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
39
Applicant Total
19
Review Days
39
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Basic Information
- Device Name
- GRAM STAIN
- K Number
- K843050
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Reagent Laboratory, Inc.
- Date Received
- August 3, 1984
- Decision Date
- September 11, 1984
- Product Code
- JTS
- 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 |
|---|---|---|---|
| JTS | Stains, Microbiologic | FDA class 1 | Hematology |
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Other Clearances by Reagent Laboratory, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863502 | SOLUTION B- NA 50MEQ/L, K 40 MEQ/L | Oct 21, 1986 | Substantially Equivalent |
| K863503 | HEMOLYSE | Oct 3, 1986 | Substantially Equivalent |
| K863550 | POTASSIUM HYDROXIDE 10% W/V | Oct 2, 1986 | Substantially Equivalent |
| K860143 | URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE | Feb 10, 1986 | Substantially Equivalent |
| K842982 | FORMALIN BUFFERED | Oct 1, 1984 | Substantially Equivalent |
| K842785 | STAIN, METHYLENE BLUE-EOSIN | Sep 11, 1984 | Substantially Equivalent |
| K841847 | LITHIUM REAGENT | Aug 17, 1984 | Substantially Equivalent |
| K843051 | WRIGHTS STAIN SOLUTION | Aug 3, 1984 | Unknown |
| K841799 | CYANOMETHEMOGLOBIN REAGENT | May 31, 1984 | Substantially Equivalent |
| K841800 | LYSING & HEMOGLOBIN REAGENT | May 31, 1984 | Substantially Equivalent |