FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BACTEC
K Number: K790899
·
Decision May 23, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
632
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BACTEC
- K Number
- K790899
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3035
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- May 9, 1979
- Decision Date
- May 23, 1979
- Product Code
- KLP
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KLP | Amikacin Serum Assay | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLP), ordered by most recent decision date.
ONLINE TDM AMIKA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIO-MONITOR AMIKACIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic
| K Number | Device Name | ||
|---|---|---|---|
| K003062 | BACTEC MGIT 960 SIR KITS | Jun 6, 2001 | Substantially Equivalent |
| K003553 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | Mar 21, 2001 | Substantially Equivalent |
| K003461 | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE | Feb 1, 2001 | Substantially Equivalent |
| K002938 | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 | Nov 29, 2000 | Substantially Equivalent |
| K001364 | BD DIRECTIGEN FLU A+B | Jun 28, 2000 | Substantially Equivalent |
| K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 25, 2000 | Substantially Equivalent |
| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 13, 2000 | Substantially Equivalent |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
| K992734 | BECTON DICKINSON SYRINGE | Oct 1, 1999 | Substantially Equivalent |
| K991551 | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | Sep 23, 1999 | Substantially Equivalent |