FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT AXSYM PROLACTIN(MODIFICATION)
K Number: K953657
·
Decision Sep 25, 1995
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
14
Review Days
69
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Basic Information
- Device Name
- ABBOTT AXSYM PROLACTIN(MODIFICATION)
- K Number
- K953657
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Mfg., Inc.
- Date Received
- July 18, 1995
- Decision Date
- September 25, 1995
- Product Code
- CFT
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFT), ordered by most recent decision date.
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SEALITE SCIENCES, INC. AQUALITE PROLACTIN
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Other Clearances by Abbott Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981457 | ALBP | May 27, 1998 | Substantially Equivalent |
| K981232 | CA | May 18, 1998 | Substantially Equivalent |
| K981231 | CO2 | May 12, 1998 | Substantially Equivalent |
| K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | Jul 3, 1997 | Substantially Equivalent |
| K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE | Jun 27, 1997 | Substantially Equivalent |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Oct 3, 1995 | Substantially Equivalent |
| K944669 | FLEXIFLO QUANTUM ENTERAL PUMP | Jul 24, 1995 | Substantially Equivalent |
| K943691 | IMX FOLATE | Mar 23, 1995 | Substantially Equivalent |
| K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP | Dec 12, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K941214 | LIFESHIELD EXTENSION SET | Oct 3, 1994 | Substantially Equivalent |