FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SQC BUFFER
K Number: K812601
·
Decision Oct 2, 1981
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
21
Review Days
18
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Basic Information
- Device Name
- SQC BUFFER
- K Number
- K812601
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Transidyne General Corp.
- Date Received
- September 14, 1981
- Decision Date
- October 2, 1981
- Product Code
- JJS
- 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 |
|---|---|---|---|
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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FDA Class 1
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Other Clearances by Transidyne General Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961217 | BODILY FLUID DISPOSAL KIT | Jul 25, 1996 | Substantially Equivalent |
| K955658 | LACERATION TRAY | Jan 25, 1996 | Substantially Equivalent |
| K950773 | PROPHYLAXIS PACK | Mar 31, 1995 | Unknown |
| K950743 | ORAL PROCEDURE PACK | Mar 31, 1995 | Unknown |
| K950449 | SURGICAL BUR | Mar 1, 1995 | Substantially Equivalent |
| K950403 | SURGICAL SAW BLADES | Feb 21, 1995 | Substantially Equivalent |
| K924811 | I.V. START KIT | Jun 17, 1993 | Unknown |
| K924243 | TRACHEOSTOMY CARE KIT | Jun 16, 1993 | Unknown |
| K922339 | SUTURE REMOVAL KIT | Dec 11, 1992 | Unknown |
| K922041 | PRIMARY SURGICAL DRESSING TRAY | Nov 6, 1992 | Unknown |