FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RETIC-SET
K Number: K841848
·
Decision May 31, 1984
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
8
Applicant Total
79
Review Days
64
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Basic Information
- Device Name
- RETIC-SET
- K Number
- K841848
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- R&D Systems, Inc.
- Date Received
- March 28, 1984
- Decision Date
- May 31, 1984
- Product Code
- KQC
- 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 |
|---|---|---|---|
| KQC | Stains, Hematology | FDA class 1 | Hematology |
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| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | Apr 28, 2011 | Substantially Equivalent |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | Jan 29, 2010 | Substantially Equivalent |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | Oct 28, 2009 | Substantially Equivalent |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | Dec 27, 2007 | Substantially Equivalent |
| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | Nov 26, 2007 | Substantially Equivalent |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | Nov 20, 2007 | Substantially Equivalent |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | Aug 20, 2007 | Substantially Equivalent |
| K070334 | R&D SICKLE QC CONTROL | Mar 29, 2007 | Substantially Equivalent |