FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DILUTOR TRANSPORTER
K Number: K780785
·
Decision Jun 14, 1978
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
44
Review Days
33
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Basic Information
- Device Name
- DILUTOR TRANSPORTER
- K Number
- K780785
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Date Received
- May 12, 1978
- Decision Date
- June 14, 1978
- Product Code
- JQW
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Hyland Therapeutic Div., Travenol Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K820835 | ALUMINA SILICA-ACTIVATED PARTIAL THROM | Apr 26, 1982 | Substantially Equivalent |
| K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | Mar 11, 1982 | Substantially Equivalent |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | Aug 18, 1981 | Substantially Equivalent |
| K810078 | Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S | Feb 2, 1981 | Substantially Equivalent |
| K810077 | OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. | Jan 28, 1981 | Substantially Equivalent |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Jan 5, 1981 | Substantially Equivalent |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | Jun 28, 1979 | Substantially Equivalent |
| K790249 | TEST CELLS | May 16, 1979 | Substantially Equivalent |
| K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING | Aug 31, 1978 | Substantially Equivalent |
| K780962 | AUTOMATED ENZYME | Jul 27, 1978 | Substantially Equivalent |