GRAM STAIN REAGENTS AND KIT
FDA 510(k) clearance K813369 · decided 1981-12-22
Clearance details
- K-number
- K813369
- Device name
- GRAM STAIN REAGENTS AND KIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1981-11-30
- Decision date
- 1981-12-22
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- JTS
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BACTIDROP CALCOFLUOR WHITE (K960095) | Remel Co. | 1996-03-19 |
| CALCOFLUOR WHITE STAIN KIT (K960090) | Remel Co. | 1996-03-19 |
| BACTIDROP INDIA INK (K920976) | Remel Co. | 1992-06-09 |
| BACTIDROP CALCOFLUOR WHITE (K920975) | Remel Co. | 1992-06-09 |
| BACTIDROP KOH (10%) (K920970) | Remel Co. | 1992-06-09 |
| IRISTAIN FORMULA 2, PARTS 1 AND 2 (K893530) | Intl. Remote Imaging Systems | 1989-06-13 |
| ATS DOBELL & O'CONNOR'S IODINE (K890861) | Alpha-Tec Systems, Inc. | 1989-03-23 |
| ATS LUGOL'S IODINE SOLUTION (K890020) | Alpha-Tec Systems, Inc. | 1989-02-24 |
| SNAP N' STAIN IODINE STAIN (K884069) | Scientific Device Laboratory, Inc. | 1988-10-25 |
| METHENO-STAIN KIT (K883052) | Scientific Device Laboratory, Inc. | 1988-08-30 |
| ATS PARA-SET CARBOL-XYLENE SOLUTION (K883061) | Alpha-Tech Systems, Inc. | 1988-08-17 |
| ATS PARA-SET IODINE ALCOHOL SOLUTION (K883049) | Alpha-Tec Systems, Inc. | 1988-08-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |