FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
K Number: K991362
·
Decision Jun 21, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
12
Review Days
68
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Basic Information
- Device Name
- HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
- K Number
- K991362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7440
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Morax
- Date Received
- April 14, 1999
- Decision Date
- June 21, 1999
- Product Code
- JBD
- 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 |
|---|---|---|---|
| JBD | System, Analysis, Electrophoretic Hemoglobin | FDA class 2 | Hematology |
Similar 510(k) Clearances
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Other Clearances by Morax
| K Number | Device Name | ||
|---|---|---|---|
| K033277 | HYDRAGEL CSF ISOFOCUSING KITS | Nov 4, 2003 | Substantially Equivalent |
| K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | Jan 17, 2002 | Substantially Equivalent |
| K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT | Dec 29, 1999 | Substantially Equivalent |
| K990250 | HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 | Jun 18, 1999 | Substantially Equivalent |
| K981048 | HYDRAGEL 6 CSF KIT | Oct 7, 1998 | Substantially Equivalent |
| K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 | Oct 7, 1998 | Substantially Equivalent |
| K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT | Mar 4, 1998 | Substantially Equivalent |
| K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT | Oct 27, 1997 | Substantially Equivalent |
| K963844 | HYDRAGEL 15 HB A1C KIT | Apr 22, 1997 | Substantially Equivalent |
| K960029 | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT | Jul 17, 1996 | Substantially Equivalent |