FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

58 results for "Kallestad Diag, A Div. of Erbamont, Inc."
49–58 of 58
Search insights Median review: 37d Cleared: 100% Top manufacturer: Kallestad Diag, A Div. of Erbamont, Inc. Lead specialty: Immunology
Cleared Jul 09, 1987
KALLESTAD QM300 IGM ANTIBODY PACK
K872237 · DFT
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 29d
Cleared Jun 12, 1987
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
K871940 · CZP
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared Jun 12, 1987
QM300 C3 ANTIBODY PACK
K871939 · CZW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared May 21, 1987
QM2/QM300 CONTROL A PACK
K871342 · JJY
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 21, 1987
QM300 CALIBRATOR A PACK
K871341 · JIX
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 15, 1987
QM2/QM300 BUFFER AND DILUENT PACK
K871343 · CFN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared May 15, 1987
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
K871339 · JQP
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared Apr 22, 1987
QM300 IGG ANTIBODY PACK
K871340 · DEW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Apr 08, 1987
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
K870963 · LIO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 29d
Cleared Feb 02, 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663 · LJP
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 66d