Atlas FDA

SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM

FDA 510(k) clearance K953317 · decided 1995-08-04

Clearance details

K-number
K953317
Device name
SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM
Applicant
Sa Scientific, Inc.
Decision
Substantially Equivalent
Date received
1995-07-13
Decision date
1995-08-04
Days to decision
22 days
Clearance type
Traditional
Product code
GNB
Device class
2
Regulation number
866.3660
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
San Antonio, TX, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Sa Scientific

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SAS SHIGELLA SONNEI FORM II ANTISERUM (K961537)Sa Scientific, Inc.1996-05-31
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) (K961528)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM (K961551)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM (K961532)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM (K961546)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 12 ANTISERUM (K961529)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM (K961535)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) (K961534)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM (K961549)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM (K961538)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM (K961554)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM (K961548)Sa Scientific, Inc.1996-05-20

Recalls involving this device

No recalls on record reference this clearance.