Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

92 results for "Kallestad Laboratories, Inc."
73–92 of 92
Search insights Median review: 28d Cleared: 100% Top manufacturer: Kallestad Laboratories, Inc. Lead specialty: Immunology
Cleared Dec 22, 1977
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
K772250 · DEI
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K772249 · CEW
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALBUMIN NEPHELOMETRIC ASSAY
K772248
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K772247 · DBI
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY
K772246 · DEB
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K772245 · DAD
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Nov 22, 1977
FLUORESCEIN CONJUGATED
K772128 · DCE
Kallestad Laboratories, Inc.
Immunology · 11d
Cleared Jun 24, 1977
GOAT ANTISERUM COMPLEMENT C3 NEPHEL.
K770964 · DAK
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 24, 1977
GOAT ANTISERUM IGM NEPHELOMHTRIC
K770963 · DFT
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 24, 1977
GOAT ANTISERUM IGA NEPHELOMETRIC
K770962 · CZP
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 24, 1977
GOAT ANTISERUM IGG NEPHELOMETRIC
K770961 · DEW
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 22, 1977
HUMAN REFERENCE SERUM
K770965
Kallestad Laboratories, Inc.
Immunology · 26d
Cleared Jun 14, 1977
TSH RADIOIMMUNOASSAY
K770892 · JLW
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 03, 1977
RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3
K770520 · CDP
Kallestad Laboratories, Inc.
Chemistry · 77d
Cleared Apr 27, 1977
IMMUNOELECTROPHORESIS PROFILE KIT
K770566 · JZS
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Apr 26, 1977
IMMUNOELECTROFILM KIH
K770719 · JZS
Kallestad Laboratories, Inc.
Immunology · 8d
Cleared Apr 26, 1977
STAIN, R-250, COOMASSIE BRILLIANT BLUE
K770718 · JZS
Kallestad Laboratories, Inc.
Immunology · 8d
Cleared Mar 21, 1977
VITAMIN B12 RADIOASSAY
K761321 · CDD
Kallestad Laboratories, Inc.
Chemistry · 84d
Cleared Aug 26, 1976
TEST, MACROGLOBULIN KIT (ALPHA2)
K760396
Kallestad Laboratories, Inc.
Immunology · 20d
Cleared Jul 26, 1976
RADIOIMMUNOASSAY
K760227 · CDX
Kallestad Laboratories, Inc.
Immunology · 14d