FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENERAL DIAGNOSTICS PLATELET ANTIBODY
K Number: K841465
·
Decision Jul 2, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
39
Review Days
84
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Basic Information
- Device Name
- GENERAL DIAGNOSTICS PLATELET ANTIBODY
- K Number
- K841465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- General Diagnostics
- Date Received
- April 9, 1984
- Decision Date
- July 2, 1984
- Product Code
- LLG
- Advisory Committee
- Hematology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LLG | Kit, Igg, Platelet Associated | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLG), ordered by most recent decision date.
View allOther Clearances by General Diagnostics
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| K863877 | BENZODIAZEPINE ENZYME IMMUNOASSAY KIT | Mar 12, 1987 | Substantially Equivalent |
| K842307 | GENERAL DIAG. CEFONICID 30MCG ANTIMIC | Jul 20, 1984 | Substantially Equivalent |
| K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK | Dec 30, 1983 | Substantially Equivalent |
| K832653 | CEFUROXIME 30MCG. SUSCEP DISK | Oct 14, 1983 | Substantially Equivalent |
| K831179 | CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP | May 9, 1983 | Substantially Equivalent |
| K830731 | NETILMICIN 30 MCG ANTIMICROBIAL DISK | Apr 8, 1983 | Substantially Equivalent |