510(k) K813391
- Device
- Tobramycin Reagent Test Kit
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K813391
- Product code
- LKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-18
- Date received
- 1981-12-03
- Classification name
- Pad, Alcohol, Device Disinfectant
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3008264111
- 3004472810
- 3015173212
- 1423537
- 3017635043
- 2029275
- 3003674698
- 2411192
- 3017299525
- 3009761558
- 3038632739
- 3019804885
- 3006897996
- 3010882065
- 3030692786
- 3010408344
- 3011835632
- 3042283853
- 3030067857
- 1018120
- 3002907620
- 9616088
- 3011427127
- 9613778
- 3027997270
- 3011529314
- 1054241
- 3003528228
- 1423507
- 3008261717
- 3035382642
- 3036978602
- 3004519921
- 3015341499
- 3033920063
- 1921846
- 3011526299
- 3013524663
- 1422634
- 3005750815
- 1055236
- 3005739529
- 3004111573
- 3010321647
- 3020978033
- 3042024535
- 3013632692
- 2243072
- 1643817
- 3006899020
- 3038276119
- 3021282544
- 3012309743
- 3002806503
- 3016674858
- 1061124
- 3016861904
- 8022656
- 1038758
- 3009732568
- 3018167761
- 3026263452
- 3038356900
- 3003902312
- 3015821396
- 3013823570
- 3024273968
- 3034605486
- 2320762
- 3009503464
- 1043214
- 3013525704
- 3008427684
- 3005674464
- 3013034812
- 3015140199
- 3004513970
- 3010623099
- 1417592
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132380 | PREVANTICS DEVICE SWAB | Professional Disposables International, Inc. | 2014-08-27 |
| K121655 | BD ALCOHOL SWAB | Becton, Dickinson & CO | 2013-03-20 |
| K112791 | SITESCRUB IPA DEVICE | C. R. Bard | 2012-02-24 |
| K912161 | I.V. STARR KIT | Medical Device Inspection Co., Inc. | 1991-10-08 |
| K912731 | STERI-SWAB | Westlock Investments (Usa), Inc. | 1991-10-02 |
| K910735 | HEXIDIS ALCOHOL SWAB | Specialites Septodont | 1991-04-02 |
| K896898 | BOWEN ELECTRODE SKIN PREPATORY CLEANSER | Bowen & Company, Inc. | 1990-04-04 |
| K896835 | ALCOHOL PREP AND POVIDONE-IODINE PREP | Norpak Mfg., Inc. | 1990-01-11 |
| K894791 | BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE | Span-America Medical Systems, Inc. | 1989-10-03 |
| K893958 | BAXTER ACETONE-ALCOHOL PREP PADS, STERILE | Span-America Medical Systems, Inc. | 1989-10-03 |
| K892193 | QUICKPAD (ALCOHOL SWABS) | Holtsch Co., Inc. | 1989-08-04 |
| K883840 | DRI-VENT ARTERIAL BLOOD SAMPLING KIT | Concord Laboratories, Inc. | 1989-05-16 |
| K890514 | PRE-MOISTENED CLEANSING PAD | Bausch & Lomb, Inc. | 1989-04-10 |
| K870718 | AMERICAN ALCOHOL PREP PAD STERILE MEDIUM | Span-America Medical Systems, Inc. | 1987-05-07 |
| K860961 | GAMMA RADIATION STERILIZED ALCOHOL PREP PADS | H & P Industries, Inc. | 1986-04-09 |