P.R.A.S. CARY & BLAIR TRANSPORT MEDIUM
FDA 510(k) clearance K770004 · decided 1977-01-14
Clearance details
- K-number
- K770004
- Device name
- P.R.A.S. CARY & BLAIR TRANSPORT MEDIUM
- Applicant
- Scott Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-01-03
- Decision date
- 1977-01-14
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- JSJ
- Device class
- 1
- Regulation number
- 866.2360
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (K882463) | Lakewood Biochemical Co., Inc. | 1988-06-22 |
| SABOURAUD MALTOSE AGAR (K881570) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| YM BROTH (K881571) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MYCOLOGICAL AGAR W/LOW PH (K881549) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CHAPMAN STONE MEDIUM (K881526) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PHYTONE YEAST EXTRACT AGAR (K881573) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| STREPTOSEL (K881578) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| BRILLIANT GREEN AGAR W/SULFADIAZINE (K881530) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| INHIBITORY MOLD AGAR (K881565) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MITIS SALIVARIUS AGAR (K881547) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TERGITOL 7 BROTH (K881561) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| LITTMAN AGAR (K881544) | Acumedia Manufacturers, Inc. | 1988-04-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S012) | Scott Laboratories, Inc. | 2016-03-15 |
| SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S011) | Scott Laboratories, Inc. | 2016-02-12 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S010) | Scott Laboratories, Inc. | 2016-01-26 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S009) | Scott Laboratories, Inc. | 2015-10-08 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S007) | Scott Laboratories, Inc. | 2015-10-06 |
| SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S008) | Scott Laboratories, Inc. | 2015-07-16 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S005) | Scott Laboratories, Inc. | 2015-03-25 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS (P080009/S004) | Scott Laboratories, Inc. | 2015-03-23 |