Atlas FDA

SHIGELLA I.D.

FDA 510(k) clearance K821337 · decided 1982-05-28

Clearance details

K-number
K821337
Device name
SHIGELLA I.D.
Applicant
Analytical Products, Inc.
Decision
Substantially Equivalent
Date received
1982-05-05
Decision date
1982-05-28
Days to decision
23 days
Clearance type
Traditional
Product code
GNB
Device class
2
Regulation number
866.3660
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.

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.

PMA approvals by this applicant

RecordFirmDate
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S010)Analytical Products, Inc.1984-05-04
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S009)Analytical Products, Inc.1984-04-24
UNISCEPT(TM) (P830028/S001)Analytical Products, Inc.1984-03-09
UNISCEPT(TM) (P830028)Analytical Products, Inc.1984-03-01
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S007)Analytical Products, Inc.1983-11-25
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S008)Analytical Products, Inc.1983-11-17
OMNISCEPT(TM) KB SYSTEM (P800029/S005)Analytical Products, Inc.1983-07-05
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S003)Analytical Products, Inc.1982-06-18